Impact of Critical Suppliers and Subcontractors on Medical Device Market Approvals

There is a growing need in the current global economy to outsource with no foreseeable turning back. Medical Device and In Vitro Diagnostic Manufacturers in the United States are in constant need to tap in new markets (Europe with CE marking, Canada with CMDCAS and soon Japan, Brazil and Australia with MDSAP), increase their ability to respond to opportunities and demands while concentrating their efforts on innovation. Without the concept of outsourcing supply chain links, the medical device market would be in slow motion and startups would struggle to exist.

In the USA only, nearly 80% of the medical device companies have less than 50 employees. This percentage could explain why the outsourcing market would be reaching 45 billion dollars in the next two years. There are advantages for manufacturers to subcontracts and common pitfalls they need to be aware of when deciding to outsource.

Join LNE/G-MED and Ehab Amen for an insight on the definitions of suppliers and supply chain outsourcing and discuss the possible impacts on the manufacturer’s certification process.

In this webinar, you will learn about:

• Impacts of critical suppliers on the Manufacturer’s Certification Process
• Definitions and approaches in auditing
• Evaluation approach of critical supplier
• Outsourcing and the role of the Legal Manufacturer