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    • Home
    • Our Services
    • Our Team
    • Blog
    • Training
    • Contact Us

  • Home
  • Our Services
  • Our Team
  • Blog
  • Training
  • Contact Us

Our services

PROJECT MANAGEMENT

 We provide practical hands on support to get your medical device idea from concept to market.

 

QUALITY ASSURANCE

  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.



 

PRODUCT REGISTRATION

 CMS SciDoc can support you to enter new markets and facilitate product registration in multiple markets. 

PRODUCT TESTING

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. 

TECHNICAL Dossiers

 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 

 Suite 3, 85 Curzon St, North Melbourne, VIC 3051 Australia 

 M: +61 417 534 122