(571) 447-5500

Jeff VanderHoek

EAS Independent Consultant

Jeff VanderHoek is a Medical Device RA/QA professional with over 30 years of experience in developing Quality Systems that meet or exceed FDA and ISO requirements and Regulatory Submissions that achieve their intended purpose. He has hosted numerous FDA and Notified Body Audits of the Quality Systems he has put in place wherein no or very few nonconformances were raised/found. He has also prepared several successful FDA Meeting Requests and IDE submissions, as well as prepared MDD submissions and an MDR submission that recently obtained the CE mark.

For over 12 years, Jeff has successfully worked with Clinical teams to put in place a Clinical System that works and meets requirements. This includes experience in working with and auditing Clinical Research Organizations used for Clinical Research Studies, as well as providing updates to Clinical Investigators and the FDA on the progress of Clinical Studies.

He has coached and developed teams at various companies designing and manufacturing various medical devices from Heart Catheters and Heart Valves to Pain Pumps and Sports Medicine Devices.

Jeff’s training includes:
• ISO 13485 Auditor Training from BSI
• MDD to MDR Transition Training from BSI
• FMEA and Risk Analysis
• 510(k) Development and Preparation from UCSD
• Design of Experiments and Statistics
• ASQ CQE Certification
• Supplier Management and Scorecards
• Software Validation
• Agile and Oracle Software Programs
• Lean Manufacturing
• FDA QSR Training
• Kepner Tragoe Problem Solving
• Project Management
• Validation and Verification Methods

Posted in Who’s Who at EAS.