Martin Leighton
Project Director

Martin Leighton is an internationally recognized subject matter expert for medical devices and bio-medical products with over 2 decades of industry experience. During his distinguished career he has consistently served some of the world's leading medical device companies while helping them bring their innovative products to market. His portfolio of satisfied clients includes: Agilent Technologies, Alcon, ARROW Int., Baxter, Genzyme, Hill Rom, Johnson & Johnson, Medtronic, MedSource, Siemens, Smith + Nephew, Respironics, TYCO, and numerous small start-up companies. As a member of the Pinnacle family Mr. Leighton continues to educate and assist industry to implement medical device reporting/vigilance, MDD, IVDD, ISO 13485/88, design controls, ISO 14971 Risk Management, US-EU MRA, CMDCAS, design dossier content, and FDA 510(k) submission strategy. His credentials and experience include:

• Executive Director of Operations and Strategic Business Development for the US Medical Division of TÜV Product Service
• Quality Management Systems & EU Notified Body Lead Assessor
• Member of the US Technical Advisory Group (TAG) to ISO TC 210 WG1 for ISO 13485
• Member of ISO TC 210 WG1 writing team for the ISO 14969 guidance document.
• Conducted compliance assessments to the requirements of the AIMDD, MDD, ISO 9000, EN 46000, and ISO 13485/88 standards for over 160 medical device manufacturers
• FDA trained for: "Pre-market Notification [510(k)] Review for Third Party Organizations" and "Quality System Regulation (QSR)-Design Controls Assessments;" as a US Conformity Assessment Body (CAB) under the US-EU Mutual Recognition Agreement (MRA).
• CMDCAS trained and certified by Health Canada
• Original member of Health Canada's CMDCAS working group