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A strategic approach towards DHF remediation of medical devices

Blog: Capgemini CTO Blog

Medical device regulations keep changing and they are becoming increasingly difficult to implement as the medical device industry evolves and adopts new technology faster than ever. One of the challenges medical devices manufacturers struggle with is planning for regulatory changes and acting on them in advance to avoid last-minute hassles. Regulations including FDA, EU MDR, EU IVDR are constantly changing and evolving. Regardless of the medical device’s lifecycle stage, the compliance issues can be a major setback. For legacy medical devices, it is a challenge to ensure that Design History Files (DHFs) for existing products are compliant with the new regulations.

We have seen that DHFs can become surprisingly complex documents as they are part of long-running development programs. A DHF is a compilation of records that describes the design history of a finished device. When remediation is required, it can pose distinct challenges to medical device manufacturers as they may not be fully prepared for this. Remediation of a quality system is a complex, time-consuming task that demands expertise and precise knowledge of procedures and risk management. Mergers and acquisitions and even change in manufacturing locations have also triggered the need to update design information files and other compliance documents for our clients.

DHF remediation includes a review of the design history files of legacy products to ensure compliance with quality system and regulatory requirements. New standards and regulations make it important to define an appropriate strategy to upgrade the DHF at the outset. With our experience, we have identified a simplistic approach to accommodate remediation for regulatory compliance.

Approach to remediation

Strategy and planning

Gap assessment

Quality system update

Closing the gaps in product documentation

Design transfer

A successful remediation project depends on many elements – a robust strategy, expert resources, and effective communication are vital aspects.

Reach out to learn more about how our industrialized approach to product remediation supports clients at an optimized cost and in a scalable, consistent, and transparent manner.

Visit our page to know more about remediation services for medical devices.

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