Regulatory Compliance, Strategy & Submissions

Did you know that many jurisdictions (e.g. (Australia, Saudi Arabia, Taiwan) offer fast-track processes for devices which hold CE or US approvals? It’s essential to appreciate the opportunities presented by mutual or unilateral recognition of regulatory certifications.

Regulatory processes and requirements vary widely. The art is in understanding the underlying technical requirements and standards and matching these to the various regulatory processes. This then allows compilation of a single regulatory data set and definition of a regulatory strategy that is efficient and provides the quickest access to markets of interest.

Our leadership team has decades of experience in regulatory systems and the evolution of the global regulatory landscape. They are supported by a team of highly trained consultants with detailed knowledge of submission requirements and processes.

We can assist you with:

  • Regulatory Strategy for one or multiple markets
  • Pre-submission consultations with regulators including US and CHina FDA’s, Notified Bodies, Australian TGA.
  • Preparation of compliant technical files.
  • Clinical Evaluation Reports for multiple markets including Europe, China, Australia
  • ISO 14971 Risk Assessments
  • Standards Compliance
    • ISO 10993 biocompatibility
    • IEC 60601 or 61010 electrical safety
    • IEC 62304 software
    • Sterility
    • ISO 22442 Animal Origin materials
  • Regulatory Guidances including FDA, NB-MED and MEDDEV.
  • CE marking
  • US 510(k), or PMA applications
  • China FDA submissions
  • Product filings and liaison with Type testing centres in otherAsian markets including Taiwan, Japan, Korea, ASEAN
  • Australian TGA ARTG registrations and conformity assessment submissions
  • New Zealand WAND filings
  • Management of filings and reviews.

Email [email protected] and we’ll be in touch right away to help speed your global regulatory approvals.

Need assistance with your Global Medical Device and IVD Regulatory Services?

We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports.  Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)

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