We have a team of experts that can provide practical, clear advice on all aspects of the quality and regulatory aspects of IVD and medical device Regulations and Standards.
We have proven experience in the following areas:
- EU IVD Regulation
- EU MDR Regulation
- IVD Design and Development
- Quality Management Systems (ISO13485:2016)
- Risk Management (ISO14971:2012)
- Global registration (FDA, Canada, Australia, South America, Rest of World)
Previously Completed Projects
MDSAP Gap Assessments
Reviewing a medium sized IVD Manufacturers Quality Management System against the requirements of the Medical De-vice Single Audit Program (MDSAP).
Providing a regulatory assessment for a Venture Capital company for a Research and Development device and prepare a strategy for placement on market within the EU under the IVD Directive, IVD Regulation and other global markets.
We also provide ongoing ad-hoc independent assessment to companies of various sizes on regulatory and quality ques-tions that are raised during product design, development and placement on market.
Interim Quality and Regulatory Management positions
We have supported small and mid-sized manufacturers and notified bodies providing short term support for Regulatory and Quality positions. We have experience in providing regulatory support and advice to top management where a quali-ty or regulatory function is not available.
Quality Management System development
Building a Quality Management System suitable for a start-up company building towards compliance to ISO 13485:2016. We provided a series of template documents to cover the main areas of a Quality Management System and adapting them to fit the specific nature and need of the company.
IVD Design and Development
Supporting a start-up company to design and develop an IVD with the goal to obtain a CE mark under the IVD Directive but building the technical file and Quality Management System compliant to the IVD Regulation.
IVDR Transition Projects
Working with large IVD companies and consultancy firms to advice on the critical issues and potential strategies for the transition of products and quality management system processes from the IVD Directive to the IVD Regulation.