Fit for MDR (Part 4 of 4) : TD Assessment

DAY & DATE: Thursday, 17th December 2020

TIME: 11.00 am IST | 1.30 pm SGT | 12.30 pm ICT

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Agenda

Our expert will provide an end-to-end overview on the following topics:

• Structure of technical documentation
• MDR Annex II Section 3b : Validations
• Devices incorporating or consisting of Nanomaterial
• Consultation of Clinical Evaluation (MDR §54)
• MDR §18 and the Influence on conformity assessment at TÜV SÜD
• Up-classification of Spinal Implants

WHO SHOULD ATTEND:

All QA & Regulatory Personnel of Medical Device Manufacturers

MEET THE SPEAKER:

Mr. Neppo Anand brings with him a rich industry experience of over 21 years. His expertise lies primarily in the field of medical devices and pharma packaging.

Mr. Anand is a PVP MSc degree holder in Applied Microbiology and has worked extensively across the pharmaceutical industry as a Quality Management System (QMS) professional.

Presently working as a lead auditor, he is also responsible for TD reviews, high risk product sterilization and packaging at TÜV SÜD’s Product Services division in India. 

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).

As a world leader, we have worked with medical device manufacturers across the world to assess the safety and quality of their devices. Our extensive experience of conducting testing on a wide range of networked medical devices, aids your compliance to regulations and access to global markets.

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.

For more information, please click here.

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