Webinar | TÜV Rheinland - Precisely Right

(Registration Closed)

Live Webinar: Medical Device Cybersecurity under EU MDR 2017/745 and IVDR 2017/746

With the rapid digitalization of the healthcare sector, spurred on by the COVID-19 pandemic, a unified, harmonized approach to establishing state-of-the-art medical cybersecurity approaches is extremely important, especially in light of the emerging threat of cybercrime.

Safety and security of medical devices is mandatory under the EU MDR (EU 2017/745) and EU IVDR (EU 2017/746). For the conformance with the General Safety and Performance Requirements (GSPR) of the regulations, appropriate evidence needs to be in place during audits and technical file reviews. The MDCG 2019-16 provides a basic guidance for cybersecurity in medical devices, and upcoming medical standards are directly targeting software development life cycle including security activities.

In this webinar, learn about key expectations by notified bodies during conformity assessments:

Background of medical device cybersecurity requirements under MDR/IVDR
Conformity assessment and technical file considerations and key expectations
Medical device software development and security life-cycle synergies

Webinar Details:

Date: 2nd December, 2021

Time: 12.30PM (India, GMT +5.30)

2.00PM (Indonesia, Thailand, Vietnam - GMT +7)

3.00PM (Singapore, Malaysia, Philippines, Hong Kong, Taiwan - GMT +8)

4.00PM (Japan, South Korea - GMT +9)

8.00 AM (Central European Time, GMT +1)

Duration: 1 Hour

Language: English

Fee: Complimentary

Featured Speakers:

1. Ferenc Kazinczi - Global Head – Medical Software Technical Competence Centre Active Medical Device Auditor

Mr. Kazinczi holds degrees in software and biomedical engineering with advanced studies focusing on AI in medical applications. He is leading the medical software, cybersecurity and AI related topics globally at TUV Rheinland and acts as an active medical device auditor for ISO 13485, MDD, MDR and MDSAP schemes. Prior to joining TUV Rheinland Japan in 2020 he gained more than 10 years of experience in the medical device industry in various roles including R&D systems engineer, project leader and product manager for high safety class devices targeting multiple markets.

2. Christophe Giraud - Project Engineer (Testing, Product Medical)

Mr. Giraud obtained a Master Degree in I.T. Engineering in France in 2010 and immediately worked as software programmer in various sectors such as water distribution, banking, pharmaceutical, cybersecurity and maritime surveillance systems. In 2018 he moved to Japan and joined TÜV Rheinland, where he is working as project engineer for testing and evaluation of Medical Electrical Equipment.