About
Hey there!
My name is Darrin Carlson, and I help medical device manufacturers sleep well knowing they are ready for an unannounced FDA inspection (or notified body audit!).
Some of my accomplishments include:
- Supporting an EU MDR QMS upgrade audit as co-lead, with zero nonconformities issued by our notified body (a first for our auditor!).
- Rescuing CAPA associated with an advisory notice at the 11th hour by ensuring that all root causes, actions, and verifications were identified and correlated. Subsequent FDA close-out included no observations, and my critical contribution was commended as “intelligent,” “organized,” “accurate,” and “succinct.”
- Leading dozens of internal audits to ISO 13485, ISO 14971, 21 CFR 820, MDSAP, and EU MDR criteria.
- Improving CAPA on-time completion metrics from 19% to 100% during QMS harmonization with legal manufacturer.
- Leading QMS team to review, approve, and release 345 change orders in one month to support successful design review.
My life has been immeasurably improved by medtech innovation. After my mom was diagnosed with cancer in 2001, I was able to enjoy 20 more years with her thanks to the treatment she received. During this time she was able to join me on a trip of a lifetime to Machu Picchu and meet her baby grandson. (I think that one was her favorite!)
This, among many other quality and quantity of life improvements for me and my loved ones, means that I intend to spend the rest of my life empowering medtech innovation by ensuring compliance and customer satisfaction.
What about credentials?
While they are no substitute for my experience, I also have the following hard-earned certifications:
- RAC-Devices–so I understand the “big picture” of getting (and keeping) devices on the market around the world.
- ISO 13485:2016 Lead Internal Auditor–so I can assess an organization’s QMS against the state-of-the-art medical device standard.
- EU MDR Internal Auditor–so I can assess an organization’s QMS against the EU’s medical device regulation.
- Project Management Professional (PMP)–so I know how to plan, execute, and get complex projects across the finish line.
Fun facts:
- I love to travel (over 30 countries visited so far) and learn languages (I’m comfortable with Spanish and Portuguese, and I can muddle through some French.)
- I taught myself to swim at the age of 30, and celebrated with a mile-long race across San Diego Bay.
- I once played a song with Green Day in front of a packed arena (and kept the guitar as a souvenir).
If you made it this far, then I’d love to stay in touch!