Daryl Wisdahl - Senior Consultant, Quality Assurance & Regulatory

Daryl Wisdahl has more than 15 years of regulatory affairs, clinical research, quality assurance, and marketing experience in the medical technology industry. He oversees Emergo's operations in western Canada and the northwest USA from his base in Vancouver, British Columbia.

In his position with Emergo, Daryl helps medical device manufacturers from Canada and around the world with issues related to Health Canada Medical Device License (MDL) applications, Technical File construction, clinical evaluations and ISO 13485:2003 implementation in accordance with the Canadian Medical Device Regulations (CMDR). Daryl also conducts training on ISO 13485, auditing and the CMDR, and assists clients with business development in Canada.

EXPERIENCE:

Director of RA & QA, Urodynamix Technologies Ltd. (2005-2007)

• Responsible for establishing the quality system, clinical research and regulatory strategy for a non-Invasive urodynamics (NIU) system.
• Managed all regulatory submission activities.
  

Director of RA/QA, VSM MedTech Ltd. (2001-2005)

• Responsible for regulatory strategy and submission activities for VSM MedTech Devices Inc. (BpTRU Vital Signs Monitor) and VSM MedTech Systems Inc. (CTF MEG System).
• Managed all quality assurance activities, including SOP preparation and review and management reviews.
  
• Acted as the company quality representative for all project teams.
  
• Performed numerous internal quality audits. Responsible for supplier qualification.
• Upgraded quality system from ISO 13485:1996 to ISO13485:2003.
• Prepared and submitted several Successful FDA 510(k) submissions (K030737, K023078, K023055, K012636).
• Obtained the CE Marking and Health Canada Medical Device Licenses for company products.

Manager, Regulatory Affairs, Response Biomedical Corp. (2000-2001)

• Responsible for regulatory and clinical strategy for a point-of-care in-vitro diagnostic device laboratory testing product.
• Drafted and executed clinical trial strategy for the RAMP System.
• Conducted negotiations and established contracts with clinical trial investigators and Clinical Research Coordinators.
• Performed marketing activities, including the development of the Operators Manual, marketing questionnaires and sales/marketing literature.
  

Manager, Regulatory Affairs and Clinical Research, Xillix Technologies Corp. (1993-1999)

• Responsible for international regulatory submissions, managing clinical trials and product management.
• Developed regulatory and strategy for the future generations of Xillix LIFE-Lung Fluorescence Endoscopy System.
• Maintained regulatory compliance with international regulatory agencies. Prepared regulatory submissions for FDA and Health Canada.
  
• Designed and oversaw clinical trials for Canada, US and the EU. Managed international multi-center clinical trials to support FDA Premarket Approval (PMA) and supervised two Clinical Specialists.
• Successfully submitted FDA PMA application for an endoscopy system with approval received in less than one-half the average approval time. Member of team which presented at FDA Panel Meeting for PMA Submission.
• Successful FDA Investigational Device Exemption submission

AREAS OF EXPERTISE:

Medical Devices:

• Dental
• Ear, nose and throat
• Imaging equipment
• Implants (non-active)
• Mobility aids
• Optical
• Lasers
• Patient monitoring
• Radiology
• Reusable instruments
• Surgical instruments

QA & RA:

• FDA Quality System Regulation (21 CFR Part 820)
• ISO 13485:2003
• Canadian Medical Device Regulations (CMDR)
• Internal auditing for QMS compliance
• Medical Devices Directive (MDD)

CERTIFICATIONS AND MEMBERSHIPS:

• Regulatory Affairs Professional Society - RAC Certification (US)
  
• ISO 13485:2003 Internal Quality Auditor Training - BSI Product Services

EDUCATION:

• Bachelor of Business Administration and Economics, Simon Fraser University.

HOME BASE:

• British Columbia, CANADA