Many small med tech companies are strapped for competent regulatory and quality resources. Companies face challenges such as budgetary constraints, gaps in subject matter expertise, changes in regulatory requirements, and variation in the frequency and scope of regulatory and quality related work. Many businesses meet these challenges by contracting consultants with specific expertise to support the variety of needed activities. A good consulting firm can provide a virtual staff that supports the company with everything from submissions, quality systems development and implementation, quality engineering, to subject matter expertise.
While a company can outsource many, if not all, regulatory and quality activities, how much responsibility for quality and business decisions can be outsourced? Does the CEO have the responsibility to understand the regulations to the extent that he or she can make appropriate business decisions and develop company strategy? Does the CEO have ultimate accountability for regulatory and quality of the business process and products?
I am interested in hearing your thoughts on the role of management responsibility and outsourcing regulatory and quality. Stay tuned to future blog posts on this topic to hear community feedback to these questions, learn how the new Medical Device Regulation in the EU impacts the discussion, and tips for executive management to mitigate risks.