Resources

• Both the PCS Regulatory Utility (PCSRU) and the PCS Manufacturing Utility (PCSMU) are designed for regulatory testing. The PCSMU allows you to make necessary adjustments to your radio including maximum transmit power levels. The PCSRU enables you to conduct regulatory domain tests that require continuous receive, continuous transmit, and continuous wave (CW) frequency.

• These utilities can be accessed for the applicable release version from the Prism Computer Solutions Software Download Center: http://www.prismcs.com

• Definition

• Classification

• Essential requirements

• Conformity assessment

• Clinical evalution & investigation

• MIC( Japan )( formerly TELEC) - Ministry of Internal Affairs and Communications.

• ETSI - European Telecommunications Standards Institute.

• KC - Korea Certification

• IC - Industry Canada.

• FCC - Federal Communications Commission.

• NCC - National Communications Commission (Taiwan).

• Ministry of Internal Affairs and Communications (MIC) (formerly TELEC) is the standards body for Japan. For more information: http://www.telec.or.jp/eng/Index_e.htm

• For MIC certifications, all approvals and certifications must exist at the device level, rather than the radio module level. Device vendors may leverage Summit's certifications and the associated test report when applying for MIC certifications.

• Article 2 Item 19, Category WW (2.4GHz Channels 1-13)

• Article 2 Item 19-2, Category GZ (2.4GHz Channel 14)

• Article 2 Item 19-2 Category XW (5150-5250 W52 & 5250-5350 W53)

• Article 2 Item 19-2 Category YW (5470-5725 W56)

• European Telecommunications Standards Institute (ETSI) is the standards body for most of Europe, Africa, the Middle East, and parts of Asia. For more information: http://www.etsi.org

• According to the Radio and Telecommunications Terminal Equipment (R&TTE) Directive, the manufacturer must issue a Declaration of Conformity (DoC) indicating device compliance with the basic requirements of applicable directives.

• For ETSI certifications, all Summit certifications may be leveraged by mobile and portable device vendors as part of their self-declaration to obtain the CE mark required by members of the European Union.

• Note: ETSI/CE rules differ from those of the FCC and IC in that there is no provision for a modular approval. All approvals and certifications must exist at the device, rather than the radio module, level.

• In some situations, the module's current test reports may not be adequate to support a DoC for the end product:

• Environmental extremes - The host (end) product may be marketed for a higher or different temperature range or a different voltage range than what was included in the module's original testing.

• Antenna - The antenna gain used by the host product may be different than with module's original test reports.

• Software - The host product may not fully incorporate some of the features present in the operating software used in the original module tests.

• Module modifications - The integrator may have to modify the module to allow it to operate properly in the host system. If so, the integrator must have a thorough understanding of the impact the changes may have on each of the module tests.

• EN 300 328 (v1.7.1) Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques; Harmonized EN covering essential requirements under article 3.2 of the R&TTE Directive

• EN 301 893 (v1.5.1) (a/b/g modules) Broadband Radio Access Networks (BRAN); 5 GHz high performance RLAN; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive

• EN 301 489-1 (v1.8.1) (Council Directive 2004/108/EC on Electromagnetic Compatibility) Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements

• EN 301 489-17 (v.2.1.1) (Council Directive 2004/108/EC on Electromagnetic Compatibility) Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions for Broadband Data Transmission Systems

• EN 60950-1 (2006+A1:2010) (Council Directive 2006/95/EC on Low Voltage Equipment Safety)

• EN 62311:2008 (Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields)

• EU 2002/95/EC (RoHS - Restriction of Hazardous Substances)

• Korea Certification (KC) is the standards body for Korea.

• On February 29, 2008, the former Ministry of Information and Communications (MIC) and the Korea Broadcasting Commission (KBC) merged to form the Korea Communications Commission (KCC) which covered EMC, Radio, and Telecom certification.

• As of January 24, 2011, the KCC mark was unified to KC (Korea Certification). For more information: KCC Certification Policy.

• The National Communications Commission (NCC), established in February of 2006, is the first legitimate regulatory agency in Taiwan that is independent from an executive branch. This commission is responsible for the regulation of telecommunications, information, and broadcasting sectors.

• The following four policies make up the administrative principles of NCC:

• Promote the sound development of communications

• Safeguard individuals' rights

• Protect consumers' interests

• Raise multicultural diversity

• For more information: http://www.ncc.gov.tw

• PCS devices with NCC certification are certified to the following NCC standard:

• LP0002 (100-06-28) Technical regulations for low power radio-frequency devices for the radiated and conducted emissions of international radiators.

• Industry Canada (IC) is the regulatory agency and standards body for Canada. For more information: http://www.ic.gc.ca/

• IC certifications are based on FCC certification testing using the same antennas and transmit power and covering the same frequency bands. Test reports and data sheets relevant to IC certification may be found in the FCC section for the applicable PCS device

• PCS's IC certifications are certified to the IC RSS-210 standard.

• RSS-210 Radio Standards Specification RSS-210, Issue 8, License-exempt Radio Apparatus (All Frequency Bands): Category I Equipment

• RSS-Gen Issue 2 General Requirements and Information for the Certification of Radio Communication Equipment

• Industry Canada ID Number

• An IC-certified device must be labeled with a unique certification number which includes:

• Company Number (CN) - Assigned by Industry Canada. Made up of (at most) six alphanumeric characters (A-Z, 0-9).

• Unique Product Number (UPN) - Assigned by the applicant. Made up of (at most) eight alphanumeric characters (A-Z, 0-9).

• Example: PCS-MSD30AG IC ID - 6616A-PCSMSD30AG

• 6616A = Company Number (CN)

• PCSMSD30AG = Unique Product Number (UPN)

• The Federal Communications Commission is the regulatory agency and standards body for the Americas and parts of Asia. For more information: http://www.fcc.gov/

• PCS radios hold the following FCC grants:

• Part 15.247 Subpart C DTS (Digital Transmission System) specification

• Part 15.407 Subpart E Requirements for UNII Devices

• The FCC certification process varies depending on the type of device you plan to certify.

• Portable Device (such as a Handheld Device)

• Portable device vendors must secure an FCC grant for their devices rather than leverage an existing grant at the module (radio) level. See "Portable Devices" for additional information.

• Mobile Device (such as a Vehicle Mounted Device)

• FCC rules allow vendors to use current FCC grants for their mobile devices without additional testing or certification only if certain conditions are met. See "Mobile Devices" for additional information.

• The FCC ID is a three letter grantee code followed by up to 14 characters of your choice. The ID can only consist of alphanumeric characters and the hyphen. The grantee code (the FCC Registration Number or FRN) is assigned to you by the FCC. If this is the first time your company is making a submittal, the grantee code will be assigned just prior to making the submittal; otherwise, you use the previously assigned code.

• Example: PCS-MSD30AG FCC ID - TWG-PCSMSD30AG.

When integrating certified wireless module into end host products, you must consider the specific FCC grant conditions for each wireless module. Common module conditions include:

• Implementation of the module according to the manufacturer's installation guidelines.

• Operation distance from the human body. If the end host product device operates close to the human body (within 20 cm), then SAR testing may be required. See Portable Devices for more information.

• Collocation restrictions with other radio technologies. If other wireless technologies are operational at the same time, then certification testing for each technology may be required.

• Antenna restrictions (antenna type and gain). If the antenna used does not meet the restrictions, additional testing is required.

Types of modular approval:

• Modular Approval

• Limited Modular Approval

Modular approvals apply to non-stand-alone products (devices that are designed for use in other end products). This type of certification enables a manufacturer to incorporate an approved module into a product without having to retest or recertify the module.

• 1. RF Shielding - The modular transmitter must have its own RF shielding; it does not rely on the shielding provided by the device into which it is installed in order for modular transmitter emissions to comply with Part 15 limits and to prevent coupling of emissions to or from the module and any wires or other circuitry resulting in non-compliant operation.

• 2. Buffered Data Input/Output Ports - The modular transmitter must have buffered modulation or data inputs (if provided) to ensure that the module will comply with Part 15 requirements under conditions of excessive data rates or over-modulation.

• 3. Power Supply Regulation - The modular transmitter must have its own power supply regulation. This ensures that the module will comply with Part 15 requirements regardless of the design of the power supplying circuitry in the device into which the module is installed.

• 4. Permanent Antenna or Unique Connector - The modular transmitter must comply with the antenna requirements from Section 15.203 and 15.204(c).

• 4a. The antenna must either be permanently attached or employ a "unique" antenna coupler (at all connections between the module and the antenna, including the cable).

• 4b. Any antenna used with the module must be approved with the module, either at the time of initial authorization or through a Class II permissive change. The "professional installation" provision of Section 15.203 may not be applied to modules.

• 5. Tested in "Stand Alone" Condition - The modular transmitter must be tested in a stand-alone configuration (i.e., the module must not be inside another device during testing).

• 5a. This is intended to demonstrate that the module can comply with Part 15 emission limits regardless of the device into which it is eventually installed.

• 6. Labeled with Own ID Number - The modular transmitter must be labeled with its own FCC ID number. If the FCC ID is not visible when the module is installed inside another device, then the host device must contain the FCC ID number with the statement such as the following: "Contains Transmitter Module FCC ID: XYZMODEL1" or "Contains FCC ID: XYZMODEL1."

• 7. Instructions to Operator / OEM Integrator - The modular transmitter must comply with any specific rule or operating requirements applicable to the transmitter and the manufacturer must provide adequate instructions along with the module to explain any such requirements. A copy of these instructions must be included in the application for equipment authorization.

• 8. Must Meet RF Exposure Requirements - The modular transmitter must comply with any applicable RF exposure requirements. FCC Rules in Sections 2.1091, 2.1093 or any specific rf exposure requirements of part 15.

If a device does not have all eight items, it may still be possible to do a Limited Modular Approval.

Limited Modular Approval (LMA) may be granted if the device does not meet all modular requirements and if compliance can be demonstrated under the operating conditions in which the device will be used. An LMA is only issued in circumstances where the Grantee can demonstrate that it will retain control over the final installation of the device (to ensure compliance of the end product).

• Note: FCC and IC approvals do not allow the use of LMAs with collocated radios nor with portable devices.

• A portable device is a device that typically transmits in direct contact or within 20 cm of the human body (such as a handheld device) under normal operating conditions.

• Because of their operation within close proximity of the human body, portable devices must undergo an additional level of testing (in addition to EMC testing) that is not required of mobile devices. This testing is referred to as Specific Absorption Rate (SAR) testing which measures the amount of energy from the device that is absorbed by the human body.

• Because SAR is very device-specific, FCC rules do not allow for a Modular Approval or a Limited Modular Approval (LMA) for use with portable devices; portable device vendors must secure an FCC grant for their devices rather than leverage an existing grant at the module (radio) level.

• A mobile device is a transmitting device designed for fixed locations and typically transmits at least 20 cm from the human body. In this context, "fixed location" indicates that the device, including its antenna, is physically secured at one location and cannot be easily moved to another location. A vehicle-mounted device is an example of a mobile device.

• Transmitting devices that can be easily re-located (such as wireless devices associated with a personal computer) may be considered mobile devices if they meet the 20 cm separation requirement.

FCC rules allow vendors to use current FCC grants for their mobile devices without additional testing or certification only if the following conditions are met:

• The radio must be set for no more than the same transmit power as was used for the grant.

• The antennas used with these devices must be of like type (i.e., dipole or monopole).

• The antennas used with these devices must be of equal or lesser gain.

• Mobile device vendors must add all necessary FCC statements to their user's manual. These statements may be found in the product Hardware Integration Guides accessed from the product specifications page for this product.

All UNII modular approvals for devices with DFS must be LMAs.

• This is typically limited to end products with external antennas.

• For modular approvals with internal antennas, different hosts will affect DFS compliance (module is limited to the specified host for DFS testing). For different hosts, a Class II Permissive Change (C2PC) with DFS testing for the new host is required.

DFS testing is also required when any new antenna with a lower gain than the original antenna is used.

A Class II Permissive Change involves a change that affects the reported performance characteristics and the test data that was submitted for the original approval. For a Class II change, the EUT (Equipment Under Test) must be tested and the test report submitted to the FCC or a TCB for approval before the change can be put into production.

The following situations would require a Class II Permissive Change filing:

• When the antenna gain of a new antenna (of the same type as the originally approved antenna) is greater than the antenna gain of the originally tested antenna.

• When the emission levels or reported RF safety levels of a new antenna (of the same antenna type) increase.

• If the new antenna is a different type, has a lower gain than the originally approved antenna, and tests show that the spurious emission levels or reported RF safety levels have increased.

The following situations also qualify for a Class II Permissive Change (and do not require a new FCC ID):

• A change from a non-modular approval to a modular approval.

• A change from a modular approval to an LMA.

• Coming into force on June 13, 2017, and half way through the transition period, the Radio Equipment Directive (RED) 2014/53/EU replaces the Radio and Telecommunications Terminal Equipment Directive (R&TTED) 1995/5/EC and over the past few months received numerous questions regarding the transition to the new directive. This isn't an all inclusive list or a full transition guide, far from it, We recommend that you consult a RED Notified Body with your specific needs for that.

• No, the RED came into force on June 13th 2016, however, article 48 gives a transitional provision accepting the old directive for radio equipment covered by the RED until June 12, 2017. That is to say you must apply the RED to covered radio equipment on or after June 13th 2017

• I get this a lot, and it's a very common misconception. One does not simply "test" to a Directive, you declare compliance to the Directive.

• The directive contains the essential requirements of compliance, among other laws, governing the "making available on the market" of Radio Equipment. Testing is one method for demonstrating compliance with the essential requirements, but the actual test methods are found outside the directive, referred to as "Harmonised Standards" under the directive.

• While in order to use a "Harmonised Standard" for presumption of conformity, it must be published with reference to the RED in the Official Journal, the new directive doesn't change harmonized standards, but it may impose new "essential" requirements that could impact your testing.

• Probably not. Article 17 of the RED describes the conformity assessment procedures. There are three annexes describing the available methods. (Annex II Internal Product Control) (Annex III EU-type examination) and (Annex IV Full Quality Assurance).

• By far Internal Production Control is the most commonly used conformity assessment method and it's the only method that does not require 3rd party involvement of a Notified Body, but in order to apply Annex II, you must test in full to published harmonized standards. The problem is that the list of harmonized standards published under the new RED is small compared to the R&TTE. Chances are at the moment the particular harmonized standard previously applied has not been adapted and referenced to the RED, but the list is growing. See https://celectronics.com/certification/europe/ for links to the published harmonized standards.

• Another issue here is that there is a change, however so slightly, in the requirements from the R&TTE article 3.2. This small change adds a new requirement to be assessed, and that is that the Radio Equipment "supports the efficient use of radio spectrum". New technical standards will need to incorporate this requirement.

• Yes, there are a couple as mentioned above, Annex III EU-Type examination and Annex IV Full Quality Assurance. Of the two, EU type examination would generally be the most practical for most organisations that don't have the ability or wish to submit to a full quality assurance assessment or the continued surveillance required of that system.

• EU-Type examination is a method by which the manufacturer submits an application to a "single" Notified Body of their choice. The Notified Body will review the technical design and verify the equipment complies with the essential requirements of the RED and if so issue an EU-Type examination certificate. This would be combined with the manufacturer's own assessment and the Declaration of Conformity (which will include the Notified Body number). The manufacturer would then affix the CE mark to the equipment (without including the Notified Body number)

• On or after June 13th 2017, all equipment that falls within the scope of the RED must be assessed to be in compliance with the RED prior to placing on the market in the European Union. This does not apply to equipment already on the market (sold or in the EU), only new shipments being placed on the market. The declaration of conformity must follow the new Model Structure and the manufacturer shall also establish the required technical documentation described in Article 21 of the RED. Also note that in addition to the technical test report the manufacturer is required to provide a risk assessment within their technical documentation.

• Free Space Loss: Signal disperses with distance; therefore signal attenuates over distance

• Atomspheric Absorption: Water vapour and oxygen in atmosphere may attenuate signals; only significant for specific frequencies (e.g. 22GHz, > 30 GHz)

• Multipath: Signals reflect off obstacles; multiple copies of signal arrive at receiver with varying delays causing reinforcement or cancellation

• Refraction: Signals are refracted through atmosphere; only part of wave received

• Parabolic antenna ( usually 1-3 m) used to transmit point-to-poing to another antenna

• Line-of-sight communications; often antennas are placed high (towers, buildings) to avoid obstacles

• Long-distance telecommunications (alternative to optical fibre, coaxial cable), e.g. voice and TV transmission

• Short communications between buildings (e.g. office buildings in city)

• Mobile telephone system (GSM, CDMA, 3G)

Band(GHz)---Bandwidth(MHz)---Data Rate(Mbps)

• 2 -------------- 7 ------------- 12

• 6 -------------- 30 ------------- 90

• 11 ------------- 40 -------------135

• 18 -------------220 -------------274

• Communications satellite acts as microwave relay station

• Links two or more ground/earth stations

• Receives signal on one frequency (uplink), repeats or amplifies, and transmits on another frequency(downlink)

• Point-to-Point or broadcast configuration

• Geostationary Orbit (GEO): satellite appers stationary from Earth; cover about 1/3 Earth surface; 36,000 km above Earth

• Low Earth Orbit (LEO): 100's of km above Earth; orbit every 1-2 hours; footprint with radius of 3000-4000 km

"Regulation: Direct uniform path applicable and binding in all EU Member States. Cocument whcih carries legal weight"

"Directives: Binding all members states to common objectives. Minimum set of requirments. Free of charge Reference can be found in official journal"

"Guidelines: Aim a common approach by all member states. Not legally binding. No legal force but expected to be followed."

"Normes: No legal force but expected to be followed. Prevention of execution, production. Control and attestation of requiremnts. International Statndardization is a multi-stakeholders process involving industry, science, academia, consumer and governments."

Instrument, apparatus, appliance, software, material or other article, intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,

• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

• investigation, replacement or modification of the anatomy or of a physiological process,

• control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

Active Implantable Devices - AIMD 90/385/EEC In-vitro Diagnostic Devices - IVDD 98/79/EC

Active implantable medical device means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure;

Active medical device means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.

In viro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

• concerning a physiological or pathological state, or

• concerning a congenital abnormality, or

• to determine the safety and compatibility with potential recipients, or

• to monitor therapeutic measures.

"Medical devices are classified according four risk levels"

"1. Class I : Low Risk Level -- Non-invasive -- less than 1 hour"

"2. Class IIa : Medium Risk level -- Invasive -- 1 hour to 30 days"

"3. Class IIb : Medium Risk Potentiel -- Implantable -- more than 30 days"

"4. Class III : High Risk Level -- Central circulary system, Central nervous system, Device incorporating a medicinal product, or animal tissue"

"Environment, destination and intended use are determinant for the classification of a medical device."

The involvement of a Notified Body(NB) is not necessary for medical devices of class I uncess they have measuring function or are placed on the market in a sterile condition.

"Medical devices are classified according four risk levels"

"1. Class I : FDA Product Registration - Minimum Risk -- Non-sterile -- Common -- approx. 14 days"

Class I Medical Devices Examples: These include: Tongue depressors, casters, traditional stethoscope, wheelchair, otoscopes, therapeutic oxygen tanks, inspection gloves, hammertoe calipers, simple devices to facilitate venous access, etc. "EZ vein" a simple class I device had fastest FDA regulatory approval in history (for non-expedited devices).

"2. Class II : Pre-Market Notification - (510(k) - Moderate risk -- SW, FW -- Diagnosis -- upto 30 days"

Class II Medical Devices Examples: These include: digital glucometers, monitor vital signs, anti-bacterial keyboards for hospital use machines in-vitro diagnostic, non-invasive electro stimulators, pathological culture materials, electrical surgical instruments and / o measurement, non-invasive meter hemoglobin (Masimo), ultrasound and endoscope machine.

"3. Class III : Pre-Market Approval(PMA) - High Risk -- Implantable -- Storng Energy Delivery -- more than 30 days"

Class III Medical Devices Examples: They include implantable pacemakers, breast implants, metal hip prostheses, artificail ventricles, tricuspid valve replacements, artificial knee implants, aortic stnts and gamma knife devices.

"Designation of Notified Body(NB)"

"1. by Competent Authority of Member State"

"2. for one or more of the conformity assessment procedure"

"Role of Notified Body (NB)"

"1. NB are independant"

"2. NB checks the conformity of the device, by exams or audits"

"3. Deliver CE certicates

"4. NB are payed for their services to customer

"5. They are not consultants

"Control"

"1. National Competent Authority periodically audits the NBs

"2. Reports to the European Commission

Selection Criteria

"1. Specialists of the field"

"2. Where close competitirs CE-marked their device"

"3. FDA third party review accreditation or close relationship with FDA"

"4. Geographical / language"

"5. http://ec.europa.eu/growth/tools-databases/nando/

• By affixing the CE marking on a product, the manufacturer declares on his/her sole responsibility that the product is in conformity with the essential requirements of the directives that apply to it (health, safety, and environmental protection) and that the relevant conformity assessment procedures have been fulfilled. Thus products bearing the CE marking benefit from free circulation in the European Market.

• Not all products sold in EU need to bear CE marking. Only about 23 categories of different products are concerned. Ex: toys, electrical devices, machinery, individual protection equipment, lift, medical devices,...

• CE marking does not mean that a product is manufactured in EU; it indicates that the product was evaluated before being placed on the market and meets EU safety, health, and environmental protection requirements.

• EU Directives: MDD 93/42/EEC Standard Medical Devices. AIMD 90/385/EEC Active Implantable Devices. IVDD 98/79/EC In-vitro Diagnostic Devices.

Steps for Manufacturers

• Affix CE Marking

Technical documents

Check conformity

Need for notified body?

Verify Requirements

Directives

• 1. Identify the applicable directives(s)

• 2. Identify the applicable requirements of the Directive(s)

• 3. Identify an appropriate route to conformity

• 4. Assessment of the product's conformity

• 5. Compile the technical documentation

• 6. Make a Declaration and affix the CE Mark

• That depends on many factors. For example, specific tests that need to be carried out, whether or not by an accredited lab, the complexity of the product, wheter the product can be shipped, whether the product already includes certified components, etc. We can provide a specific cost estimate in the form of a quote.

• On average, certification takes six to eight weeks for a single product. This depends on the test results, whether the product still needs to be modified, and how quickly the technical documentation can be supplied. If it is urgent, we can fast-track the process, depending on the product.

• There are no hallmarks that apply globally. If you wish to offer your product to the market worldwide, we can prepare a customized strategy. It is important that we start with the markings with the most stringent criteria.

• 1. Photos or drawings of the product to be certified

• 2. A description of the product's intended use

• 3. General technical specifications of the product

• 4. Test reports, certificates, and other related documents, if available.

Even when your product is already certified and you only wish to have the certification checked, you can contact us . We offer full product certification, but a standalone technical inspection or separate legal assistance is no problem either.

• 1. RF Power

• 2. Frequency Error

• 3. Bandwidth

• 4. Spurious Emissions.

• 5. Audio performance

• 6. Receiver performance

• 7. SIM Test

• 8. Protocol tests

• 9. Interference

• 1. Write step by step operating procedure and work instructions.

• 2. Carefully follow written procedures and instructions.

• 3. Promptly and accurately document your work for compliance and traceability.

• 4. Validating work ensures that the system is doing what it is designed to do.

• 5. Develop a good design for the facility and the equipment from the begining.

• 6. Properly maintain the facility and the equipment.

• 7. Clearly define, develop and demonstrate job competence.

• 8. Protect drug products against contamination by practicing good hygene.

• 9. Design Quality in the prodcut manufacturing.

• 10. Perform regular Audits.

Medical Devices 21 CFR 820

Subpart A - General Provisions  Subpart B - Qualtiy System Requirements 
- 820.1 Scope  - 820.20 Management Resposibitiy 
- 820.3 Definitions  - 820.22 Quality Audit 
- 820.5 Quality System  - 820.25 Personal Requirements 

Subpart C - Design Control  Subpart D - Document Control 
- 820.30 Design Control  - 820.40 Document Control 

Subpart E - Purchasing Controls  Subpart F - Identification and Traceability 
- 820.50 Purchasing Control  - 820.60 Identification 
  - 820.65 Traceability 

Subpart G - Production and Process Controls  Subpart H - Acceptance Activities 
- 820.70 Production and process controls  - 820.80 Receiving, in-process and finished device acceptance 
- 820.72 Inspection, measuring and test equipment  - 820.86 Acceptance status 
- 820.75 Process Validation   

Subpart I - Nonconforming product  Subpart J - Corrective and Preventive Action 
- 820.90 Nonconforming product  - 820.100 Corrective and Preventive Action 

Subpart K - Labeling and Package Control  Subpart L - Handling, Storage, Distribution and Installation 
- 820.120 Device Labeling  - 820.140 Handling 
- 820.130 Device Packaging  - 820.150 Storage 
  - 820-160 Distribution 
  - 820-170 Installation 

Subpart M - Records  Subpart N - Servicing 
- 820.180 General Requirements  - 820.200 Servicing 
- 820.181 Device Master Records   
- 820.184 Device History Records   
- 820-186 Quality system Records   
- 820-198 Complaint Files   

Subpart O - Statistical Techniques   
- 820.250 Statistical Techniques   

• 1. Investigational Device Exemptions (IDE)

allows an investigational device to be used in a clinical study to collect the safety and effectiveness data.

• 2. Premarket Notification (510(k))

Used when it is possible to demonstrate substantial equivalence to a legally marketed device (Predicate Device). Multiple or "split" predicates might be used..

• 3. Premarket Approval Applications (PMA)

to evaluate safety and effectiveness of Class III devices or devices that were found not substantially equivalent to a Class I or II predicate. PMA(cost) Approx. 10 * 510(k)(cost).

• 4. Humanitarian Device Exemption (HDE)

device that is intended to benefit patients of acondition that affects fewer than 4000 individual.

Product approval requires a compliant Qualtiy Management System(QMS)

• General Controls

• General Control and Special Controls