CMS SciDoc Pty Ltd

CMS SciDoc is an Australian regulatory and quality management consultancy supporting medical device, IVD and SaMD manufacturers with market access, regulatory compliance and quality management requirements worldwide. With in-depth experience across MDR, IVDR, TGA, US FDA and international regulatory requirements, we help manufacturers navigate the complexities of bringing medical technologies to market and maintaining compliance throughout the product lifecycle.

Our services include regulatory submissions and market access, Technical File/Design Dossier preparation, ISO 13485 implementation, ISO 14971 risk management, conformity assessment coordination, clinical and regulatory medical writing, CERs, PMCF, SSCPs and PSURs, as well as internal and supplier audits.

We also provide Local Authorised Representative and regulatory support across multiple markets, including Australia, New Zealand, Europe, China, India, Southeast Asia, the UK and the USA.

Our goal is to make international market entry simpler and more manageable for medical device manufacturers by combining regulatory expertise, practical quality management support and local representation.

At MEDICA 2026, we look forward to connecting with manufacturers, technology companies and industry partners seeking practical regulatory and quality solutions for their global expansion.

Visit CMS SciDoc at MEDICA 2026 to discuss your device, regulatory pathway or market entry plans with our team.