What Medical Device Risk Compliance Certifications do you recommend?

A

Agent J

#1
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.
 
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Mark Meer

Trusted Information Resource
#2
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?
As risk-based approaches to all processes are increasingly emphasized, knowledge of a risk management framework and principles (such as ISO 14971) becomes invaluable to quality system managers.

How your company divides responsibilities is their decision. It is often the case that ISO 14971 risk management activities is headed by a project manager (which doesn't necessarily entail ISO 13485 background).

In short, my opinion is that persons responsible for risk management needn't (necessarily) be versed in quality system standards, whereas those persons responsible for quality system management should be versed in some sort of risk-management principles.


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)
Personally, I wouldn't put too much stock in such "official" qualifications. Experience is infinitely more valuable. If you are involved in the risk-management process for a number of projects, that is, IMO, better on your resume than a weekend certification course... ;)
 
A

Agent J

#3
Thank you for the reply, Mark.

Personally, I wouldn't put too much stock in such "official" qualifications.
I would tend to agree with you. Part of my asking is management has tasked me to investigate how things are "normally" done in the industry. It sounds like pursuing certifications wouldn't provide much value compared to doing the job.

Are there any conferences that you would suggest for continuing education and rubbing elbows with more experienced individuals?
 

Mark Meer

Trusted Information Resource
#4
...Part of my asking is management has tasked me to investigate how things are "normally" done in the industry...
"Normally" is not necessarily a goal to pursue, as systems will always be tailored to a company's unique requirements (e.g. nature of their activities and devices they sell, system/organization structure and resources... etc.).

If you've got a copy of the most recent edition of ISO 14971, check out the Annexes, and they should give you a basic starting point. ...you can then tailor a framework (evaluation system, acceptance criteria, spreadsheets for documenting hazard identifications and evaluations...) to suit your needs.

Alternatively, you can obtain some risk files through Freedom of Information (FOI) requests, or search the net for examples of how other companies conduct/document their risk management activities...

:read: :agree1:
 
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