Regulatory Affairs Services

We help medical device manufacturers to meet the requirements of the Regulations on Medical Devices. We provide our expertise from help writing the regulatory strategy, guidance and support during all stages of product development, to review product technical files documentation for a successful product registration.

eQMS Implementation

If your organization plan to implement an electronic quality management system compliant with ISO13485, 21CFR820, 21CFR 11, ISO9001, ISO27001, MDSAP, we can help you meet many of the requirements of these standards, by using Atlassian Confluence & Jira Software Integration.

ISO13485/QMS MDR Implementation

Do you need ISO 13485 or QMS MDR 2017/745 for an effective implementation of the New European Medical Device Regulations?

Our Regulatory Affairs and Quality Assurance team can help you understand, plan and implement both ISO 13485, and MDR 2017/745 QMS.

As part of implementation, get all our ISO 13485/MDR QMS templates for free