Training
The CRO Group offers training services to companies in the medical device and IVD industries to comply with FDA-QSR, Part 11, ISO 13485:2016, Canadian MDR (SOR 98-282), EU MDR and IVDR regulations, and MDSAP.
Our Trainers are accredited Notified Body/MDSAP Lead Auditors, well versed not only in ISO 13485:2016, but also ISO 14971, 62304, 82304, 62366, as well as in adapting AGILE/SCRUM to IEC 62304 SDLC.
On Site
CRO Group on-site training starts with the client providing project files related to the training. CRO Group trainers work the information into the training to provide custom training that is tailored to your situation. We’re not just about slide presentations – CRO Group integrates workshops where the students participate in what they’ve learned.
“Our trainers didn’t just go through slides – we all were in hands-on workshops where we had to apply what we learned. You don’t forget THAT.” – Cathy B, Diagnostic Imaging Co
On Line Interactive and Slide Decks
CRO Group realizes that your development staff can be in multiple countries. That’s why we offer both On-Line Interactive as well as Slide Decks in our Training Resources. On Line Interactive and Slide Deck training is offered in English and Mandarin. On Line Interactive features a native speaker who in addition to going through the slides answers questions in real time. Many clients purchase Slide Decks for their Training Library – especially with the staff turnover common with SaMD / digital health companies.
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