Why Simple

Transfers Win

ECM notified body 1282

Great certification processes are simple ones. The most powerful processes live at the intersection of clarity, expertise and efficiency. By embracing simplicity and good planning, ECM delivers a quick and high quality certification process that drives business results.

Transfer to ECM, the wisest choice for an easy, simple
and streamlined Transfer experience.

Manufacturers of medical devices allocate resources, time and energies to obtain their certification. For these manufacturers transferring their Certificates or switching Notified Bodies is not an easy decision.

It is essential to have confidence in your Notified Body partner. Your NB should be a partner that adds value to your business. If your current Notified Body is not on your wavelength, is not able to react to the latest developments or is not providing you with the services you expect, transferring your certification is the right choice for you.

We are proud to offer an efficient and easy Transfer process.

ECM’s 4 steps process:

1. We provide a complete transfer plan with timeframe and milestones that you can monitor in real time.

2. Your application is the kick-off for the transfer process.

3. ECM’s team of experts carries out a thorough review of your documentation to assess the need for an on-site audit. ISO 13485 transfer requires an assessment visit.

4. After a successful outcome from the steps above, ECM will issue your certificate.

Transfer best practice

ECM is certain that building confidence and mutual understanding is the key to delivering an efficient and high quality CE Marking (link to CE Matters)  and Quality Management System (link to ISO 13485 matters) transfer process. From the very beginning ECM will focus on establishing open communications in order to avoid delays and misunderstandings.

Important Documents for the Transfer

  • Audit reports from the previous Notified Body
  • Certificates for the product(s) of the transfer
  • Agreement between the manufacturer and previous NB (we supply an agreement template)
  • A report of any non-conformities and related action plan
  • A report of any adverse events, like customer complaints and recalls, since the last audit.

Through these Documents ECM, as the entering NB, will have a full picture of the product and of the previous assessments. This enables us to set up the most efficient and cost-effective transfer.

Let's talk about

ECM America -Unit 506 – 1110 Brickell Avenue 33131
Miami, Fl

(833) 326-2378info@ecmmedicaldevices.com

ECM HQ - Via Ca' Bella, 243, 40050
Valsamoggia (BO)

+39 051 670 5141info@entecerma.it