Digital Dialogues On Demand Webinars

Stay up to date on what's shaping the medical device industry

Stay up to date on what's shaping the medical device industry

Digital Dialogues Vol. 4, organised in October 2022, consisted of a series of live deep dive sessions where global experts and industry thought leaders discuss current challenges facing the medical device industry. Our Testing services webinars (deep dive sessions) and MedTech Strategy Forums are now available on-demand so here's your chance to watch it if you didn't manage to catch it previously. Uncover in-depth knowledge from executives and experts in the field, focusing on Cybersecurity, testing for biocompatibility, reusable devices, packaging and more.


Topic: MedTech Strategy Forum Part 1: Panel with TÜV SÜD executives 

Speakers: Dr Royth von Hahn, Julia Hoyer, Dr Andreas Stange, Dr Tobias Beck, Dr Abtin Rad

Description: Meet our executives and get valuable first-hand information on TÜV SÜD’s vision, strategy and positioning in the medical device and in-vitro diagnostics market. Learn how they view the amended EU regulations and their impact on the industry. We are confident that these insights will help you successfully align your regulatory activities with your business strategy and address the complex challenges you currently face as a medical device manufacturer.

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Note: The video was recorded in October 2022 – no liability for any changes.


Topic: MedTech Strategy Forum Part 2: Panel with industry executives 

Speakers: Martin Witte (TÜV SÜD), Prof Dr Christian Johner (Johner Institut GmbH), Dr Volker Lang, (SVP Research & Development, BIOTRONIK SE & Co. KG), Dr Bálint Várkuti (CEO CereGate GmbH)

Description: Meet globally renowned executives from MedTech manufacturers and consultancies. Learn what they think of the industry’s future, upcoming developments, innovations and business model transformations and patient safety in context of these innovations.

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Note: The video was recorded in October 2022 – no liability for any changes.


Topic: Toxicological risk assessment and medical device biological safety

Speaker: Tyler Hollingshaus, Matthew R. Jorgensen (Teleflex)

Recording language: English

Description: Toxicological risk assessment, based on the results of chemical characterization, has become central to evaluating a medical device’s biological safety. This presentation will provide a brief overview of how toxicology fits into biocompatibility. Furthermore, it will work through some examples of how chemistry, followed by toxicological assessment, has been applied to medical device changes.

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Note: The video was recorded in October 2022 – no liability for any changes.


Topic: Recent experiences planning and remediating chemical characterization studies

Speaker: Tyler Hollingshaus, Eric Sussman, MCRA (USA)

Recording language: English

Description: Extractables analysis of medical devices is often performed to meet the requirements of chemical characterisation (ISO 10993-18) and leveraged to evaluate certain biocompatibility endpoints. Although extractables studies are seen as desirable alternatives to biological testing, they can have long lead times to completion, be costly to perform and be subject to careful regulatory scrutiny. Regulatory agency requests for study remediation – particularly requests for repeated testing – can have significant effects on project timelines and budgets. Therefore, it’s critically important to plan extractables studies using current best practices and customised approaches suited to the device’s composition and intended use. This Deep Dive session will draw upon MCRA’s recent experience as biocompatibility regulatory advisors, in which we have facilitated successful planning of extractables studies and remediation of agency deficiencies. We will discuss strategies for use of best practices, pilot studies, and pre-submissions to improve the likelihood of successful regulatory outcomes.

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Note: The video was recorded in October 2022 – no liability for any changes.


Topic: Transport simulation, ageing and sterile barrier system testing

Speaker: Daria Meusburger, Wolfgang Jakobi

Recording language: English

Description: Transport simulation and the testing of the ageing and sterile barrier system often pose difficulties for manufacturers, e.g.: which standard is appropriate or how to be compliant?

Each standard has its pitfalls, which we will address in this Deep Dive session by highlighting their differences. Especially with the MDR in place, various parts are challenging as they are rather ambiguous. Thus, we will look at these sections and focus on avoiding common additional-testing-based misunderstandings or gaps in know-how so you can claim equivalence in the packaging in front of the Notified Body.

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Note: The video was recorded in October 2022 – no liability for any changes.

 

 

 

 


Topic: The role of IEC 81001-5-1 in cybersecurity

Speaker: Jan Küfner

Recording language: English

Description: This Deep Dive session will cover highlights from MDCG 2019-16 and give you insights into 81001-5-1. Furthermore, we will explain the change in approach from “penetrate & patch” to “secure development life cycle”. In a final Q&A session, we will answer your questions.

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Note: The video was recorded in October 2022 – no liability for any changes.


Topic: Strengthening the science of device processing

Speaker: Tyler Hollingshaus, Terra Kremer (Johnson & Johnson)

Recording language: English

Description: This Deep Dive session will focus on how we as an industry can improve the science of technical competency while helping our individual companies and the industry by generating research and publishing collaboratively to advocate for standardization changes with data. It describes recent data generated to improve the foundation science of device processing and explore research around test soil formulation, drying, material affinity versus application method, extraction eluent/methods and improving the protein BCA method for detection.

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Note: The video was recorded in October 2022 – no liability for any changes.


Topic: A guide to defend your medical device against cyberthreats

Speaker: Jan Küfner

Recording language: English

Description: In this Deep Dive session, we will concentrate on the highlights of MDCG 2019-16 and examine common pitfalls for MDR technical documentation with regard to cybersecurity. We will also discuss the importance of testing and provide information on services available from TÜV SÜD.

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Note: The video was recorded in October 2022 – no liability for any changes.


Topic: Requirements on wireless communication for IoMT devices (Internet of Medical Things)

Speaker: Thomas Ring, Matthias Stumpe

Recording language: English

Description: More and more medical devices (medical things) are connected to the internet, either by wire or wireless.

If the communication between the medical device and other medical devices, other information technology (IT) systems or cloud platforms is realized wireless, additional requirements apply, and manufacturers need to provide objective evidence for compliance.

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Note: The video was recorded in October 2022 – no liability for any changes.

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