Eleven Borders Pty Ltd

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 processes 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.