Paul L. Clark

Founder and Director

Paul L Clark is a seasoned veteran in the Medical Device (MedTech) industry with over 30 years of experience. He has a diverse background, having worked in various capacities such as regulatory affairs, quality management, clinical research, product development, and operations.

Throughout his career, Paul has worked for regulatory agencies in Australia, Canada, the US, and Europe, and has also worked with startups and medium-sized MedTech companies in Australia and the US. He possesses a unique skill set that combines his regulatory, quality, and clinical background with proven commercial experience, including the successful launch of MedTech products in the ANZ market.

Paul's experience spans a range of active and non-active MedTech technologies, including implantable devices, cardiovascular, ophthalmic, drug delivery, renal, gastrointestinal, surgical, intensive care, wound care, imaging, mental health, monitoring devices, Software as a Medical Device (SaMD), wearable technologies and other digital health technology.

He has direct experience working with the TGA as a medical device evaluator, has been a CE Lead Auditor with TUV SUD, worked with the Canadian Medical Devices Bureau, and has dealt directly with the FDA for over 30 years. Paul has also worked directly with a number of startup MedTech ventures both in the US and Australia, and as an independent consultant/founder of Paul L Clark and Associates and Eleven Borders Pty Ltd.

If you need help navigating the global regulatory landscape throughout concept/feasibility, product development, commercialization, and post-market, Paul is the person you should talk to. His expertise traverses the regulatory borders of all key markets, including Australia, the US, the EU, the UK, Canada, and Asia.