Quality In, Quality Out: Regulatory Drivers of Supplier Quality Management in the Medical Device Industry

The MedTech supplier pyramid is complex, often with a multi-level supply chain providing parts that feed up into the finished device. It is the organization at the end of this chain that regulators hold responsible for product safety issues. Therefore, it is critical that this organization is aware of and abides by all the applicable regulations.

In this on-demand webinar, Phil Johnson, Senior Director of Quality and Compliance Services for IQVIA, provides insight on the regulatory requirements for supplier management for the MedTech -- medical devices and in-vitro diagnostics -- industry. Discussion includes a look at updates to the ISO 13485:2016 standard, and the EU Medical Device Regulation (MDR) that will increase the requirements for supplier management and drive the need to take a risk-based approach to supply chain management.

Additional topics to be addressed in this presentation include:

• The criticality of strengthening supplier monitoring
• Specific needs, by country, of the Medical Device Single Audit Program (MDSAP)
• An overview of 21 CFR Part 820, providing guidance on how the FDA interprets purchasing controls for manufacturers and their suppliers
• Analysis of the most common FDA enforcement actions, and current statistics on the increase in product recalls for medical devices

Watch this on-demand webinar to learn more. »