Paul Rowden - Medical Devices Project Director
With over twenty years’ experience in the Medical Industry, I am a highly regarded global Quality Assurance (QA) and Regulatory Affairs (RA) specialist.
I am accredited as an internationally certified Principal Auditor and have been instrumental in QA and RA strategy for the largest medical device and IVD manufacturers in the US, Canada and Europe. I have been at the forefront of class IIa, IIb and III medical devices, in the capacity of director, consultant, third party auditor and as a technical training instructor.
I have successfully guided over 400 clients to ISO, FDA, Canadian and CE compliance with the development and improvement of Quality Management Systems (QMS) and Technical Files.
My extensive knowledge within both the regulatory compliance and quality assurance field has included holding key positions as an internationally certified principal and lead auditor.