Martin Leighton, Principal of RA/QA International is a Bio-Medical Engineer and
was formerly Executive Director of Operations and Strategic Business Development
for the US Medical Division of TÜV Product Service, a Division of TÜV America,
Inc. Martin has worked with companies such as Agilent Technologies (now Phillips
Medical, formerly HP Medical Products), Chiron Vision, Alcon, Bausch & Lomb,
Teleflex Medical/Arrow Int., Baxter, Colorado MEDtech, Genzyme, Hill-Rom, Johnson &
Johnson, Medtronic, MedSource, Siemens, Smith + Nephew, Respironics, TYCO (Sherwood,
Davis+Geck, USSC), C. R. Bard, Bristol-Myers Squibb Medical Imaging and many more.
RA/QA International provides hands-on consulting services to the medical devices
industry for regulatory submissions, compliance and quality management systems.
Recently RA/QA International, L.L.C. has also added ISO 14644 clean room certification
services to its product offering.
Martin was trained at the FDA’s Staff College for “Pre-market Notification 510(k) Review
for Third Party Organizations” and “Quality System Regulation (QSR)-Design Controls Assessments.”