Product quality and regulatory compliance for medical devices are one of the most stringent requirements that contribute to product success and access to the markets. The total cost of quality for the medical device industry, including the cost and revenue loss from the quality and regulatory issues can be up to 20 percent of industry revenue.
Remediation is a complex, time-consuming task but also a key strategy for the medical devices industry to gain/ retain market access, ensure conformance to evolving standards and regulations and keep their products relevant. Planned remediation can help to keep the costs down to a small fraction of what the costs could be due to a recall or adverse reviews by the authorities especially when up to 80 percent of product launch cost is consumed on regulatory conformance activities across the product lifecycle.
Remediation requires expertise and a clear understanding of procedures and risk management associated with the product lifecycle. Capgemini’s Remediation services with an established delivery model and device modality expertise have consistently enabled our clients to achieve their goals with remediation. We have supported our clients in remediation arising out of requirements like:
- Market expansion, faster time to market
- Regulatory implications arising from
- Adoption of digital technologies
- New regulatory guidelines (e.g. MDR, IVDR, UDI, FDA)
- Significant impact of quality on top and bottom line, and reputation
- Focus in-house resources to engage in core R&D and product development
- Limited expertise to support full-cycle remediation activities
We offer the following services to help regulatory compliance for our clients:
- Gap Assessment – Safety & Performance & Technical Documentation
- Remediation for European Union Medical Device Regulation (EU MDR)
- Remediation for US Food and Drug Administration (FDA)
- Remediation for In-vitro Diagnostic Device Regulation (IVDR)
- Remediation for M&A