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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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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.
€ 975 Member | € 1,155 Nonmember
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Germany VAT number: DE329690496
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Day 1 – 23 February 2023
Intro to cybersecurity
Security by design
Security risk management and threat modeling exercise
Ben and Alf
Close for the Day
Day 2 – 24 February 2023
Threat modeling exercise, contd.
Security standards, certification
Documentation, governance, and other considerations
Shared responsibility and the hospital view
Ben KokxDirector 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 LudwigProduct 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.
Holiday Inn Munich – City Centre
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