Medical devices – cybersecurity

Cybersecurity has become a fundamental requirement for connected medical devices, systems, and hospital networks. Connectivity and networking of medical devices and systems enables new, advanced services, as well as significant efficiency gains. Real-time availability of data and remote monitoring and control capabilities offer significant value and cost benefits. However, connectivity also entails risks and opens products and systems to cyber threats. Previous cases of hacks on medical devices such as insulin pumps and pacemakers highlight these risks. Real attacks on hospital networks are increasingly taking place, leading to downtime and cancellation of treatments. This can have fatal consequences for patients.

Regulators worldwide have taken action and formulated cybersecurity requirements for medical devices, systems, and networks. Compliance is required in all major markets. SGS offers a comprehensive range of services in the cybersecurity field. These services extend from training, audits, vulnerability assessments, reviews, and cybersecurity testing to certification services.


  • Introduction to cybersecurity (CS) for medical device manufacturers
  • CS risk management according to ISO 14971, AAMI TIR57, or AAMI SW 96
  • Activities related to post-market cybersecurity
  • Secure lifecycle of hardware / software development
  • Security by design: training on secure design and coding principles
  • Security assessment and testing
  • Communication and network security


Armin Hudetz
Fon: +49 (0)89 787475-133
Fax: +49 (0)89 1250406-4100
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Customer Service
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Related links


Deutsche Akkreditierungsstelle

D-PL-11020-03-01, D-PL-11020-03-02, D-PL-11020-03-03

IEC CB-Scheme CBTL Certificate






FCC approval (CAB) by Bundesnetzagentur

USA / Canada Product Safety

Authorization for OSHA-NRTL, ISO 17065 and Standards Council of Canada (SCC)

ISO 14001 : 2015
Environmental Management System

SGS Germany GmbH, Certificate ISO 14001 : 2015


Japan – VCCI-Registration

Member-No. 2793

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SGS Germany GmbH
E-Mail: Tel.: +49 89 787475-100

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