Managing your Medical Device suppliers – Tips for ensuring they are truly FDA compliant

Using suppliers is a necessary process for most medical device manufacturers. To ensure the safety, efficacy and compliance of every facet of your end product, it is just as necessary to closely manage and audit your suppliers as it is to manage other product functions like design, sales or marketing.

It is important to remember that you are completely responsible for your suppliers’ FDA compliance status and for all finished products and services received.

In this article, Michele Bohn discusses how to choose the right suppliers, service providers and sub-tier suppliers, and how to monitor them to ensure FDA compliance.

Langage: Anglais

Auteur

Michelle Bohn

Michelle Bohn is president and CEO of Guideline Medical. Her international business and medical manufacturing career has involved leading large-scale medical and industrial manufacturing projects across the US, Asia and Europe, including: ISO 13485 certifications, medical device risk assessments, medical facility audits and FDA regulatory clearances. Michelle is a certified Six Sigma Black Belt and holds an MBA with a focus on strategic planning. She has successfully completed RAPS medical-device regulatory certificate programs and is an active member of MedTech in Upstate New York.