• Consulting Service
      Prism Computer Solutions, Inc(PCS) 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.

      Our Capability also covers:

      • 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.
      • 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.
      • 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.
      • PCS 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 PCS 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 :

    .. ..