Daryl Wisdahl


Senior Consultant, Quality and Regulatory Affairs

Daryl Wisdahl has more than 25 years of experience in the medical device industry and specializes in Quality Management System (QMS) implementation and compliance, and regulatory submissions for medical devices. Daryl’s quality background includes: implementing quality management systems, QMS and supplier audits to FDA QSR, ISO 13485, In Vitro Diagnostics Directive and Regulation (IVDD and IVDR), Medical Devices Directive and Regulation (MDD and MDR), and MDSAP. As a Senior Consultant, Daryl has reviewed Health Canada submissions, FDA submissions, and Technical Files for medical device manufacturers around the world. He assists with regulatory, quality, clinical, and general business strategy development for medical device companies. He currently supports manufacturers in the US, Canada, and internationally.