Europe CE marking

C-REG Medical guides your company onto the European market


A high-level experience on medical devices and in-vitro devices allows me to address your needs whatever they be... 

I can assist you on a wide variety of issues to comply with European requirements:

• assuring a smooth transition between MDD (93/42/CE) & MDR (Medical Device Regulations 2017/745)

• assuring a smooth transition between IVD (98/79/CE) & IVDR (ivd Regulations 2017/746)

• determining the correct product classification

• identifiying appropriate conformity assessment routes to the CE marking

• developing the Technical File (Essential Requirements, Declaration of Conformity ...)

• assuring that Risk Analysis requirements are met (ISO 14971)

• creating and implementing a quality system (ISO 13485)

• assisting with Competent Authority Inspections

• completing Internal Quality Assurance Audits

• interfacing with Competent Authorities

• complying with the post-market requirements including vigilance systems for Users, Distributors and Agencies

• supporting Clinical Studies & Clinical Evaluations for the CE marking
  

• personalised surveillance of regulatory evolutions

Many other European directives are related to Medical Devices such as the WEEE / ROHS Directives:
C-REG Medical can help you determine which directives apply to you and how to ensure conformity.

Have you thought about training ?

Your regulatory issues could be first addressed by training your team involved in the CE marking.
Any training program will be tailored to your needs, taking the profile of your team into account.

For more details or to discuss other projects, please contact C-REG Medical.