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Medical device regulatory and quality system requirements are complex. Understanding the requirements specific to your company can by difficult.

We can help you and your team become comfortable navigating these systems by providing customized training that addresses the issues that are relevant to your company’s products and business strategy.


  • Development and delivery of customized training specific to your company’s products and markets
  • Development of customized training modules that you can roll out to new and existing employees at your own schedule
  • Audit preparedness training
  • Software development and verification best practices per IEC 62304
  • Cybersecurity management best practices according to current FDA, Health Canada, and EU Guidance
  • Risk assessment training and facilitation per ISO 14971:2019
  • Training on EU MDR, FDA, and Health Canada regulations and approval pathways