Medical device manufacturers and their 21 CFR PART 820 supply chain partners must get their products to market quickly while facing new technological challenges, global competition, and the need to mitigate risks. Medical devices with electrical, mechanical, and software components introduce even more obstacles as companies strive to navigate the ever-evolving regulatory compliance initiatives for the FDA (e.g., 21 CFR Part 11 and Part 820), ISO (e.g., 13485, 14971), UL, OSHA, and environmental compliance (e.g., RoHS, conflict minerals).
So how can medical device manufacturers keep track of and successfully meet regulatory compliance requirements?
The best way to navigate compliance from early research and development to clinical trials and through commercialization is by keeping all of the quality and product information controlled in a single system of truth. Past approaches leveraging multiple “best of breed” solutions created silos of disconnected information that made it difficult to track the product design, quality issues, and compliance status.
For today’s medical device innovators with distributed supply chains, everyone involved in designing, sourcing, testing, building, and shipping devices must have access and visibility to ensure everyone is collaborating around the latest information. This requires quality records and processes that are linked to the product design for identification, analysis, and quick resolution of issues. Using this product-centric approach to a quality management system (QMS) gives impacted teams the ability to manage new product development and related quality actions in a single system to simplify compliance, reduce audit risks, and get safe and effective products to market.
In this white paper, we explore five keys to success for regulatory compliance:
- Why Product-Centric QMS Is Best
- Strategic Advantages
- Strategies for Managing Environmental Compliance
- How to Reduce Obsolescence Risks
- Connecting the Customer Feedback Loop