Regulatory Affairs

Different Regulatory Requirements are applicable depending on which market you are entering  and on the classification of Medtech device. 

The consultants at Orderly People offer qualified support for all types of Regulatory Affairs, regardless of the market and product.

In addition to that, Orderly People also supports you with:

• Act as Person Responsible for Regulatory Compliance, PRRC, and implement surveillance of Medtech device post market release

• Implementation of Post Market Surveillance, PMS and create/update of Technical Files.  

• Perform Gap-analyses of the QMS towards ISO 13485 with regards to MDR and IVD/IVDR 

• Act as support within product  classification in the EU and/or the US

• Assist with the application and contacts to Notified Bodies