WHY CHOOSE CE MARKING CERTIFICATION MDR (EU) 2017/745 FROM I3CGLOBAL?

 We are a company dedicated to regulatory compliance services across the globe.

 

We offer:

  • Certification of the CE marking according to MDR (EU) 2017/745, which allows you to use the CE mark on your products.
  • Effective and efficient certification, at your company headquarters or at the manufacturing site, thanks to our global network of local offices.
  • Certification options under MDR (EU) 2017/745, including site audits in Annex IX and XI of Part A and evaluation of Technical File.

 

Find out how you can get the CE mark for your medical device>

 

Active participation in working groups established by the European Commission and competent authorities offers us the latest compliance knowledge to satisfy your CE Marking Certification requirements. 

 

We offer you access to expert knowledge, a global network of auditors, and the opportunity to combine CE Marking with our wide range of regulatory certifications in a single audit.

 

INDEPENDENCE AND IMPARTIALITY

 

In order to comply with the EU regulations 2017/745 and 2017/746 on Medical Device CE Marking and in-vitro diagnostics, the management team of the accredited body I3CGLOBAL has signed the declaration of interest.

 

Contact us today to get CE marked and sell your MDR (EU) 2017/745 certified medical devices in Europe.

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