Consulting Service

Prism Computer Solutions, Inc(PrismCS) is responsible for developing regulatory strategies, preparing U.S. as well international submissions(RF/Medical) and obtaining approvals on time to support delivering products for worldwide market.

Completed Date: 23-12-2023
Category: Technology
Client: Robert Fox
Location: fot kde, USA

Our Capability also covers:

With our comprehensive training and expert support, you’ll be equipped to navigate complex regulations and bring your products to market with confidence.

Working with our client's team and business unit Regulatory Affairs Specialists (RAS) to provide regulatory strategy/support on change assessments for approved products. We work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.r
Support for Preparing FDA annual report submissions for all medical products and product changes as required to ensure timely approvals and maintain good standing with the regulatory bodies
Reviewing product/manufacturing process changes, supplier changes, new and revised engineering protocols and reports, and product labeling/compliant caution and warning statements.
Manage and update product dossiers and technical files for Client products.
Capable of performing theoretical SAR calculations, run simulations, and manage SAR testing as well review final reports for agency approval world wide.
Participate in project meetings and provide feedback to product development teams on regulatory issues and questions.
Maintain proficiency and standard changes to meet worldwide regulatory requirements; continually monitor changes to regulatory requirements and communicate this information to departments within the business unit that may be affected by these changes; establish and maintain good relationships with agency personnel.
Monitor and assist to interpret latest FDA regulatory environment and assess impact to approved products.
Assist company for departmental procedures for quality system compliance by reviewing internal quality procedures.
Perform various client's administrative duties, including back-up assistance for Regulatory Affairs Database.
Collaborate with cross-functional teams to develop and implement best practices that ensure the timely release of product and meet regulatory requirements and business needs.
PrismCS effectively communicates information, status, and resource requirements with client's regulatory operations team and management as requested weekly or biweekly.
Thorough knowledge of medical device product development and design control to meet customer needs.

In additions PrismCS work with the agencies and test labs during and after testing as well as reviews all test results for finalization of the test reports

Agency Approval Plan

Prism Computer Solutions (PrismCS) provides a comprehensive Agency Approval Plan to ensure your products meet all regulatory requirements for global market acceptance. This includes mapping out the approval processes for various regions, identifying necessary certifications, and coordinating with regulatory bodies. We work closely with you to develop a timeline and checklist that aligns with your product development schedule, ensuring smooth navigation through complex regulatory frameworks. PrismCS also manages communication with agencies, tracks application statuses, and resolves any queries or issues that may arise during the approval process. Our goal is to minimize delays and ensure your product is market-ready on time.

Feasibility Study

Our feasibility studies evaluate the technical, regulatory, and commercial viability of your product concept. PrismCS conducts a detailed assessment of your product design, intended use, and target markets to identify potential challenges early in the process. We analyze regulatory requirements, engineering constraints, and market-specific demands to provide actionable recommendations that optimize your development strategy. This proactive approach ensures that your product meets compliance standards while staying within budget and timeline constraints.

Design Review

PrismCS offers thorough design reviews to ensure your product meets all regulatory, safety, and performance standards. Our experts evaluate every aspect of your product design, including hardware, software, and mechanical components, to identify potential issues and suggest improvements. We assess design documentation, engineering protocols, and risk management plans to ensure compliance with global regulatory requirements such as FDA, CE, and IEC standards. This collaborative process helps refine your product, enhancing its reliability, manufacturability, and regulatory readiness.

Regulatory Research

Our team conducts detailed regulatory research to keep you informed about the latest compliance requirements and standards. PrismCS investigates regional and international regulations relevant to your product and industry, providing insights into certification pathways, testing protocols, and documentation requirements. We identify applicable standards such as FCC, ETSI, MIC, or ISO and provide a clear roadmap for compliance. Our research ensures that your product development process aligns with current regulatory expectations, reducing the risk of non-compliance and costly delays.

RF Interference and EMC Compliance During Qualification

PrismCS specializes in managing RF interference and EMC (Electromagnetic Compatibility) compliance during the qualification phase of your product. Our experts conduct rigorous testing to identify and mitigate potential sources of RF interference, ensuring your product functions reliably in its intended environment. We analyze your product’s design, materials, and operation to ensure adherence to global EMC standards, such as FCC Part 15, CISPR, or EN standards. By collaborating with test labs and agencies, PrismCS ensures accurate qualification results and provides recommendations to address any compliance gaps. This thorough process helps safeguard your product’s performance and regulatory acceptance.

Consulting Service