{"id":15,"date":"2024-03-21T14:28:17","date_gmt":"2024-03-21T14:28:17","guid":{"rendered":"https:\/\/qarasolutions.wpenginepowered.com\/?page_id=15"},"modified":"2024-05-16T02:18:43","modified_gmt":"2024-05-16T02:18:43","slug":"about","status":"publish","type":"page","link":"https:\/\/qarasolutions.com\/?page_id=15","title":{"rendered":"About"},"content":{"rendered":"\t\t
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Hey there!<\/strong><\/h1>

\"\"<\/p>

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!).<\/p>

Some of my accomplishments include:<\/strong><\/h2>
  • Supporting an EU MDR QMS upgrade audit as co-lead, with zero nonconformities issued by our notified body (a first for our auditor!).<\/li>
  • 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.”<\/li>
  • Leading dozens of internal audits to ISO 13485, ISO 14971, 21 CFR 820, MDSAP, and EU MDR criteria.<\/li>
  • Improving CAPA on-time completion metrics from 19% to 100% during QMS harmonization with legal manufacturer.<\/li>
  • Leading QMS team to review, approve, and release 345 change orders in one month to support successful design review.<\/li><\/ul>

    \"\"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<\/em> meet her baby grandson. (I think that one was her favorite!)<\/p>

    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.<\/p>

    What about credentials?
    <\/strong><\/h3>

    While they are no substitute for my experience, I also have the following hard-earned certifications:<\/p>

    • RAC-Devices<\/strong>–so I understand the “big picture” of getting (and keeping) devices on the market around the world.<\/li>
    • ISO 13485:2016 Lead Internal Auditor<\/strong>–so I can assess an organization’s QMS against the state-of-the-art medical device standard.<\/li>
    • EU MDR Internal Auditor<\/strong>–so I can assess an organization’s QMS against the EU’s medical device regulation.<\/li>
    • Project Management Professional (PMP)<\/strong>–so I know how to plan, execute, and get complex projects across the finish line.<\/li><\/ul>

      Fun facts:<\/strong><\/h3>

      \"\"<\/p>

      • \u00a0I 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.)<\/li>
      • I taught myself to swim at the age of 30, and celebrated with a mile-long race across San Diego Bay.<\/li>
      • I once played a song with Green Day in front of a packed arena (and kept the guitar as a souvenir).<\/li><\/ul>

        If you made it this far, then I’d love to stay in touch! <\/strong><\/p>

        Sign up for my free QMS Insider newsletter below.<\/strong><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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