Transition to EU MDR with ease.

Outsource CERs and SOPs to meet
MEDDEV 2.7/1 Revision 4

May 2020 is the deadline for medical device manufacturers to comply with the EU MDR. Clinical Evaluation Reports (CERs), essential to obtaining a CE mark, can be complex and time-intensive, and there's not much time left to meet compliance standards.

With Novatek's CER solution, you can meet the upcoming deadline with ease. We'll help identify what’s missing in your existing report, collect and assess the clinical data,  and compile the CER.

Our complete EU MDR compliance solution includes:

  • Clinical Evaluation Reports
  • Post-market surveillance plan and reports
  • Standard Operating Procedures
  • Instructions for Use (IFUs)
  • QMS documentation

With Novatek, May 2020 will feel like any other month.

Get started today.