- Clinical Development Consulting
- Product Development
- Training and Education
At Eleven Borders, we are dedicated to helping start-ups and medium-sized businesses navigate the complicated regulatory requirements and barriers of the MedTech industry, adopting global strategies and solutions. to comply with international regulatory requirements. In addition to our experience in the industry, we provide an established international network, strong leadership, and a team-oriented approach to medical device regulation, focusing on the implementation of process to ensure the long-term success of our clients. Our services include regulatory, clinical, and quality assessments, strategies, and planning, implementation of quality management systems (QMS) according to ISO 13485/21 CFR 820, internal and external auditing, conformity assessment to the Australian Medical Device Regulations and the EU Medical Device Directive 2017/745, technical files and dossiers, FDA consulting including pre-submissions (Q-Subs), 513(g), 510(k), De Novo and PMA submissions, and breakthrough device designation; clinical research strategies and planning, clinical study reports and clinical evaluation reports (CERs), and vigilance and post-market surveillance.
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 startup and medium-sized MedTech companies. He possess 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 active implantable devices, digital health, and Software as a Medical Device (SaMD), cardiovascular, ophthalmic, drug delivery, renal, gastrointestinal, surgical, intensive care, wound care, imaging, and monitoring devices.
He has a 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 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.
