TBD

Speaker:

Jayanth Katta
Regulatory Lead, Medical Devices
BSI

• Reviewing the process to becoming EU MDR compliant
• Assessing where the bottlenecks are
• How to use the extra year due to the delay

Speaker:

Jeffrey Cyr
Senior Manager, Regulatory Affairs
Sirtex Medical, Inc

Every organization is grappling with its own set of EU MDR triggered challenges. Three years into the MDR transition period, manufacturers are realizing the consequences of deferring implementation. There is an urgent need to figure out and implement sustainable solutions for MDR compliance and beyond. With initial submissions underway and feedback being received from the Notified Bodies, it is time to take a step back and look at the challenges & learnings holistically.

Based on its experience in partnering with multiple OEMs in their individual MDR journeys, Tata Elxsi plans to share a summary of major challenges and its consolidated learnings. The webinar would cover areas like technical documentation management, post-market surveillance, clinical affairs, supplier coordination, and global regulatory processes and decisions. Furthermore, learn about solutions and options available, best practices discovered, and innovative ideas that could help the manufacturers smoothen their MDR transition as they approach the next phase of the journey.

Speakers:

Vamsi Ravali
Regulatory Compliance Leader
Tata Elxsi

Ajay Zinage
EU MDR Transition Leader
Tata Elxsi

Monali Bhansali
PMS & CER Leader
Tata Elxsi

In this session, we will cover:

• Requirements for literature during clinical evaluation planning (under the MedDev Guideline and MDR)
• Best practices on formulating your systematic literature search
• Case study on CER planning by applying the frameworks Embase offers

Speaker:

Dr. Iveta Petrova
Product Lead
Elsevier B.V.

The COVID-19 situation had undoubtedly created significant challenges for the medical device manufacturers and Notified Bodies. Both, in terms of maintaining the supply chain and performing the necessary audits and assessments. Proactive auditing is key to ensure the various requirements in terms of supplier quality, GxP standards, and technical documentation are met.

With travel restrictions and social distancing measures in place, in some cases, the MDCG allows Notified Bodies to perform remote audits. The main objective is to ensure the supply of medical devices continues, without jeopardizing the quality of the devices and their manufacturing processes. Notified Bodies can leverage technology to perform required audits remotely.

Join this session to learn:

1. A Notified Body perspective towards remote auditing
2. TÜV SÜD's most recent remote auditing experiences
3. How Notified Bodies and manufacturers can leverage technology
4. Veeva’s vision to enable remote auditing in a compliant and easy to use way
5. Adjusted ways of working to expect post-COVID-19

Speakers:

Annemien Pullen
Director Strategy, Vault Medical Devices & Diagnostics
Veeva Systems

Andreas Purde
Unit Manager, Active Medical Devices
TÜV SÜD Product Service GmbH

Carl Ning
Sr. Director, Vault Quality Medical Device & Diagnostics
Veeva Systems

• Tips and tricks for streamlining the EU MDR certification process
• Biggest hurdles faced with the EU MDR
• Key strategies that help achieve a CE mark under the EU MDR
• Differences between class 1 and class 3 compliance paths

Speaker:

Shokoufeh Khodabandeh
MDR Implementation Lead
Institut Straumann AG

TBD

Speaker:

Dr Andreas Stange
Vice President MHS Global IVD
TÜV SÜD