We provide practical hands on support to get your medical device idea from concept to market.
CMS SciDoc Quality Specialists work with clients to design and implement QM Systems (QMS) in compliance with ISO 13485, MDSAP, MDR Article 10 and 21 CFR Part 820. We prepare Quality Manuals, SOPs and QMS documentation and systems, conduct internal audits and support clients through Notified Body and FDA audits. We can also become your ongoing Management Representative, supporting your company's QMS long term needs.
CMS SciDoc can support you to enter new markets and facilitate product registration in multiple markets.
CMS SciDoc understands the regulatory requirements for product testing. We can facilitate product testing in accordance with regulatory requirements with our affiliations of local and international laboratories.
CMS SciDoc's technical and medical writing team can work with you to deliver technical documentation (for example, Clinical Evaluation Reports, Usability Reports, Biocompatibility Reports, 510k submissions, MDR Technical Dossiers, TGA Conformity Assessment Dossiers etc) according to your product's regulatory requirements.
CMS SciDoc Pty Ltd
Unit 1B, 85 Curzon St, North Melbourne, VIC 3051 Australia
M: +61 417 534 122