A
Hey Cove members.
I stumbled into the world of medical device compliance a couple years ago when I applied for an internal position at my company specific to risk compliance for the FDA/ISO 14971. At the time we had little to no experience in just what this role meant and I have spent most of my time focused on learning the medical device regulations and building a compliant risk management system for our regulated products.
I’ve finally reached a point where I can take a breath and I’m looking for how to advance my career through continued education and certifications:
1) Looking around the Cove and Google, it seems that most companies have one position for managing the quality system (ISO 13485, etc…) and risk (ISO 14971, etc…), where my company has these responsibilities split. Is this accurate?
2) What certifications, degrees, etc… would you suggest for bolstering my qualifications in medical device risk management? (When I was promoted to the role, I took a BSI certification course for ISO 14971)
Thank you in advance.
I stumbled into the world of medical device compliance a couple years ago when I applied for an internal position at my company specific to risk compliance for the FDA/ISO 14971. At the time we had little to no experience in just what this role meant and I have spent most of my time focused on learning the medical device regulations and building a compliant risk management system for our regulated products.
I’ve finally reached a point where I can take a breath and I’m looking for how to advance my career through continued education and certifications:
1) Looking around the Cove and Google, it seems that most companies have one position for managing the quality system (ISO 13485, etc…) and risk (ISO 14971, etc…), where my company has these responsibilities split. Is this accurate?
2) What certifications, degrees, etc… would you suggest for bolstering my qualifications in medical device risk management? (When I was promoted to the role, I took a BSI certification course for ISO 14971)
Thank you in advance.