- To assist and guide and/or represent manufacturer to ensure all the responsibilities complying in accordance to updated UK MDR 2002 regulations.
- To assist in approval and regulatory compliance of Medical Device and IVD as per the new EU Medical Device Regulation (2017/745)
- To assist in approval of medical device by In Vitro Diagnostic Regulation (2017/746)
- To assist in Medical Device Registration Services such as:
- MHRA Registration for UK market
- MHRA Classification
- UKCA or UKNI certification
- CE to UKCA to UKNI certification
- CE marking service for EU region
- We have a team of skilled regulatory specialists who can assist you with PRRC services and get you regulatory compliant in accordance with MDR 2017/745 and IVDR 2017/746 if you intend to market your product in the EU and if you need PRRC (Person Responsible for Regulatory Compliance) services.
Regulatory Compliance
Regulatory Compliance
