What sets our courses apart from all of the other medical device training courses out there? Watch this video to learn about our vision for medical device training.
ISO 13485:2016/FDA Part 820 QMS Training (Fundamentals)
This course covers every aspect of the essential standards and presents users with case studies and effective solutions. It provides a solid foundation to build a better understanding as to why each regulation exists.Enroll
Medical Device Verification and Validation (Introductory)
In this training we will be focusing on verification and validation and change control. This will be a high-level overview of the topics. Basically, the who, what, when, where, and why.Enroll
EU MDR (Fundamentals)
If you work with medical devices being imported or distributed in the EU, you need to know how to comply with EU MDR.
GCP – Good Clinical Practice (Fundamentals)
This course covers all clinical research standards: FDA regulations (IDE, IRBs, etc.), ICH E6, and other international standards.
We do more than just training.
Get expert advice for every step of your journey in bringing your medical device to market. Our engagement models range from full-service, individual, or customized services across Strategy, Regulatory, Clinical, Quality and Training areas of focus.