Medical Device Regulatory Career Training:

A recent question from one of my webinars and my response:

I attended the recent Medical Device labeling webinar and I have a question... 
Mr. Lincoln, as someone who is just getting started in my work with medical
devices, would you recommend the RAC training and certification? Is there
another training that you would recommend that will help me understand the
registration process as well as make me an appealing candidate for medical
device roles?
I appreciate any advice you can offer!

My answer:  

RAC certs are useful to employers to see a basic level of expertise in devices.  I also recommend knowledge of technical writing, verbal communication skills, ability to read drawings / drafting, some basic business / industrial statistics / 6 sigma / SPC.  Learn the basics of the 510(k) and the applicable CGMPs (devices are 21 CFR 820) which can be self-taught off the FDA's website. The FDA has many guidance documents of 510(k)s, IDEs, PMAs, DeNovo, the CGMPs, clinicals, data integrity, cybersecurity, etc., which are good to read, reread to gain familiarity of basic regulatory requirements.  If you're in devices, also look at pharma, etc., for principles that apply to all, e.g., the 2011 guidance document on pharma process validation which discusses basic statistical principles of reduction of variation, homogeneity within lots, consistency between lots, etc., a common goal of all manufacturing. 

And, or course, selective appropriate webinars.

Best regards, John

jel@jelincoln.com