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12.0

RAC Credits

In-Person

Europe

Thursday, 23 February 2023 (9:00 AM) - Friday, 24 February 2023 (5:00 PM) Central European Time (CET)

Holiday Inn Munich – City Centre

Hochstr. 3

München, Germany, 81669

Cybersecurity has proven a challenge not only in ensuring the security of medical devices and health software, but also preparing documents for regulatory submissions. Health authorities in many regions, including the US, Europe, Australia, Canada and Japan, have released new cybersecurity guidance documents and are updating and creating regulations to address the concerns of the new digital age. Next to the market access requirements for manufacturers, hospitals are challenged to improve their security to comply with critical infrastructure and privacy legislations, driving additional security requirements into the products, services and solutions they use, both medical and non-medical.

Join Ben Kokx and Alf Ludwig for two-day workshop that will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global regulatory and customer cybersecurity expectations.

In addition, technical staff will benefit from a better understanding of how to translate regulatory expectations into design and development activities. Organizational leaders will gain strategic knowledge that will increase the likelihood of successful submissions and help establish trust with customers who have concerns about risks related to medical devices on their networks.

REGISTRATION FEES

€ 975 Member | € 1,155 Nonmember

VAT Policy
In compliance with regulations, a 19% VAT tax will be charged to all attendees, regardless of your country of origin.

If you have a VAT number or if the company or organization you are affiliated with has a VAT number or equivalent tax registration number, you will be asked to enter it during the registration process. If you do not have a VAT number, enter No VAT. Please observe that the stated VAT number needs to be valid. Click here to check and validate your VAT number.

RAPS EU Business Information
Germany VAT number: DE329690496
For matters relative to billing, our recorded business address is: RAPS EU, Avenue de Tervueren, 188A - Box 4, 1150 Brussels, Belgium
When registering for our events, note all Credit and Debit card transactions are debited at the point of purchase

Agenda

Day 1 – 23 February 2023

9:00 (CET)	Intro to cybersecurity	Ben
*10:30*	*Break*
11:00	Regulatory overview	Ben
*12:30*	*Lunch*
13:30	Security by design	Alf
*15:00*	*Break*
15:30	Security risk management and threat modeling exercise	Ben and Alf
*17:00*	*Close for the Day*

Day 2 – 24 February 2023

9:00 (CET)	Threat modeling exercise, contd.	Ben and Alf
*10:30*	*Break*
11:00	Security standards, certification	Ben
*12:30*	*Lunch*
13:30	Documentation, governance, and other considerations	Ben and Alf
*15:00*	*Break*
15:30	Shared responsibility and the hospital view	t.b.d.
*17:00*	*Close for the Day*

Speakers:

Ben Kokx
Director of Product Security at Philips

Ben Kokx has over twenty years of product security experience within Philips, which he joined in 2001 as a software designer. He quickly moved into a new role as a product security and privacy officer and worked as such in several business and market positions. As Director Product Security, within the central Philips Product Security Office, his main responsibility is security related standards and regulations. Since 2013 Ben is also responsible for the Philips global Product Security Policy and Process Framework.

Ben is a healthcare and IoT security expert who leads and participates in many industry associations and standard development organizations like ISO/IEC JTC 1/SC 27, IEC ACSEC, IEC TC62/ISO TC 215 – JWG7 and others. He is the convenor of CEN/CENELEC JTC 13/WG 6 and 8 on product security, leading the development of European harmonized standards for security under the EU-RED. Ben is an ENISA eHealth cybersecurity expert, chairs the COCIR Cybersecurity focus group, is vice-chair of the MedTech Europe Cybersecurity workgroup, and through DITTA, participates in several public-private organizations such as the IMDRF cybersecurity workgroup.

Alf Ludwig
Product Security End-to-end Business Process Expert at Philips

Alf Ludwig had joined Philips Healthcare in 2001. He is working in the Product Security - Regulatory & Standards team as Product Security End-to-end Business Process Expert. Prior to this role, he had been doing development of medical software products and service tools, project management, and maintenance of product security processes in a Philips Business’ Quality Management System for 25 years. He holds a university degree for Electric Engineering from the University of Stuttgart, Germany.