Medical devices regulatory consultancy services by Ethiobiomedical
Ethiobiomedical provides a range of medical devices regulatory consultancy services to medical device companies including manufacturers and distributors. These consultancy supports include- ISO 13485-2016 and additional Quality management system related regulatory requirements, medical devices registration documents compilation support (based on Submission Table of Contents by International Medical Devices Regulators Forum (IMDRF) and jurisdiction specific marketing authorization requirements, devices registration process handling on behalf of manufacturers or product owners, post-market surveillance and vigilance investigation supports, etc. Please click on the following links to get details of the regulatory supports you need.
Medical device and IVDs Regulatory Registration Consultancy
ISO 13485-2016 Compliance support for Certification and Regulatory Audit
Development of documents templates for manufacturers to adapt and use for regulatory compliance
- ISO 13485 mandatory documents templates
- ISO 14971 documents templates (including Risk management procedures, Risk management plan, and hazard traceability matrix)
- Templates for some selected technical studies needed to support the registration submissions.
