DIGITAL HEALTH & PHARMACEUTICALS
Connected medical devices, health software and AI-based diagnostics bring real benefits to patients and care teams. They also bring new risks in two areas:
- Safety: infusion and insulin pumps, ventilators, monitoring systems and AI that supports image analysis or diagnosis must work reliably, including when hardware or software fails.
- Cybersecurity: patient data must stay confidential and intact, and connected devices must not be manipulated, controlled remotely or shut down by an attacker.
Manufacturers have to demonstrate both under the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), with growing expectations from the EU AI Act and data protection law. CertX helps you assess and reduce these risks with independent technical expertise.
Medical devices and health software must protect sensitive data, and critical equipment must never be hacked, controlled remotely or shut down.
Functional safety and software assessment
We assess the safety-related design and software of medical devices and health software against:
- ISO 14971 – Application of risk management to medical devices
- IEC 62304 – Medical device software life cycle processes
- IEC 60601-1 – Basic safety and essential performance, including programmable electrical medical systems
- IEC 82304-1 – Health software, general requirements for product safety
Cybersecurity
- IEC 81001-5-1 – Security activities in the health software product life cycle
- MDCG 2019-16 guidance on cybersecurity for medical devices
- FDA premarket cybersecurity expectations for devices sold in the United States
- IEC 80001-1 and ISA/IEC 62443 for hospital networks and operators
We offer two levels: a gap analysis based on your documentation and interviews, with a report of findings and recommendations, and an independent assessment that gives you evidence for your technical documentation and your notified body.
Details on our assessment process and certification process. For a quote, contact us.
Artificial intelligence in medical devices
AI-based medical devices that require a notified body under the MDR or IVDR will also be high-risk AI systems under the EU AI Act, with requirements applying from 2 August 2028. We assess your AI system against the ISO/IEC AI standards on data quality, robustness, bias and explainability, together with ISO 13485 (quality management for medical devices) and IEC 82304-2 (health and wellness apps). We help you connect these requirements with your existing MDR, IVDR and GDPR processes. More on our AI page.
Training
Our crash course Cybersecurity for medical devices covers the MDR requirements, IEC 81001-5-1 and the FDA expectations. We also run Red Belt courses on ISA/IEC 62443 and functional safety, and in-house training adapted to your team. See our training page.
Our experts in functional safety, cybersecurity and AI work together on your medical device. Contact us to discuss your project.
Is CertX a notified body under the MDR?
No. CE marking of medical devices under the MDR or IVDR is done by a notified body for these regulations. CertX provides independent technical assessments of safety, software, cybersecurity and AI that you can use as evidence in your technical documentation and in the review by your notified body.
Which cybersecurity standard applies to medical devices?
The MDR requires protection against unauthorised access in Annex I. IEC 81001-5-1 defines the security activities across the health software life cycle and is the reference standard in Europe, complemented by the MDCG 2019-16 guidance. For the United States, the FDA expects comparable evidence in premarket submissions.
Does the EU AI Act apply to my medical device?
If your device contains an AI system and needs a notified body under the MDR or IVDR, the AI system is classified as high-risk. Following the 2026 Digital Omnibus amendment, the related requirements apply from 2 August 2028 and are assessed as part of the MDR or IVDR conformity assessment.
Our experts in functional safety, cybersecurity and AI work together on your medical device. Send us the form below and we will contact you.