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MDR Certification - Plan and prepare early - A Notified Body Perspective

MDR Certification - Plan and prepare early - A Notified Body Perspective

Day & Date: Monday, 13th April, 2020

Time: 12 noon IST

Duration: 1 Hour

ABOUT THE WEBINAR:

MDR certification is going live from May 2020. All companies applying for CE for their new Medical Devices would need to prepare and plan / start early to adhere to the new Medical Device regulations as prescribed. There are many changes which have happened over the previous MDD regulations.

One of the critical aspect is the Technical Documentation and QMS compliance requirement.

FOCUS:

Our expert will extend an overview on the MDR certification and the areas to focus on.

WHO SHOULD ATTEND THE WEBINAR:

All QA & Regulatory Personnel of Medical Device Manufacturers

HOW CAN TÜV SÜD HELP YOU?

TÜV SÜD Product Service is among the world's first certification bodies to receive designation as a Notified Body for the new Medical Device Regulation by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG).

With more than 750 medical device professionals in more than 30 locations worldwide, we are the largest EU Notified Body globally authorised to provide certification services under the new regulation. We have MDR / MDSAP in-country authorized auditors, with Certification across classes of devices. First Class III device approved by TÜV SÜD under MDR. To know more click here.

OUR SERVICES AND SCOPE INCLUDE:

  • CE Marking
  • EN ISO 13485:2016
  • ISO 15378
  • 10993 Series - Bio-compatibility testing
  • EMI / EMC & Safety Testing for Active Devices under 60601-1&2
  • INMETRO (Brazil)
  • IEC - 62304 (Medical Device Software)
  • To know more, click here.

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