August 2018 Posts

Exploring Supplier Quality Management for MedTech

Exploring Supplier Quality Management for MedTech

Phil Johnson, Senior Principal, Quality and Compliance Services, IQVIA

As MedTech manufacturers, do you have the right business and regulatory processes in place to manage your respective supplier management responsibilities? Last week, I presented Part 2 of Pilgrim Quality Solutions’ 4-part webinar series, Quality In, Quality Out, taking an in-depth look at supplier quality management (SQM) processes for both medical device and in-vitro diagnostic medical device manufacturers. The key takeaway from the presentation? These manufacturers need to secure and maintain effective supplier agreements to manage both the regulatory and business needs of the product/material or service being provided.

During this webinar, I laid out the regulatory drivers for medical device supplier quality management and the importance of Quality in the evaluation, monitoring, and approval of suppliers. I also provided guidance for suppliers regarding how they manage their relationships with the legal manufacturers of the product. At the conclusion, I brought it all together by highlighting the prominence of SQM-related FDA 483s. (more…)

Supplier Quality Management in the Medical Device Industry

Supplier Quality Management in the Medical Device Industry

Daryl Oldham, Product Marketing Manager, Pilgrim Quality Solutions, an IQVIA company

When I recapped the first webinar in Pilgrim Quality Solutions’ Quality In, Quality Out: Supplier Quality Management four-part series, I started my blog with two questions:

  • Do you have the proper process in place to evaluate, monitor, track, and rate your suppliers?
  • How confident are you that you can rely on your suppliers or even that you are protected from issues your suppliers encounter at any of their locations?

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