Cybersecurity requirements in MedTech

Even when #cybersecurity is included in #MedTech product development, it is often still treated as a technical detail rather than what it actually is: a regulatory and business-critical requirement.

Under #MDR and #IVDR cybersecurity is directly tied to market access. Weak or late security work doesn’t just create technical debt. It can delay approvals, increase remediation costs, or stop a product from being launched altogether.

Building security in from the design phase, and validating it continuously, is increasingly a prerequisite for operating in regulated healthcare markets.

Read our article: https://www.assured.se/areas/medtech-security/cybersecurity-requirements-in-medtech

EU Tightens Cybersecurity Requirements for Medtech - MDR and IVDR

The EU is strengthening cybersecurity requirements in MDR and IVDR. Manufacturers must embed cybersecurity from the start, document processes, and ensure security throughout the entire device lifecycle.

Assured AB

What are the biggest challenges in the field of #ClinicalDecisionSupport?

In our current conceptualisation of the Clinical Decision Support Network (CDSN), we have asked ourselves precisely this question. What's the sticking point in the scientific community?

The results are clear: meeting regulatory requirements and working together in multi-centre collaborations.

Sounds familiar? Let's get in touch to solve these problems together in the #CDSN!

#CDS #CDSS #MedicalAI #MDR #IVDR

EPP piles pressure on Commission for revision of medical devices regulation

Peter Liese's resolution will be voted on by MEPs on Wednesday.

EURACTIV
Jumping right in with a familiar #MedicalDevice topic close to the #MedTech industry, Europe's #MDR and #IVDR -- perhaps a future #BusinessCase about needing to find that delicate balance between #Regulatory and #Innovation. https://www.reuters.com/business/healthcare-pharmaceuticals/medical-device-makers-drop-products-eu-law-sows-chaos-2022-12-19/
Medical device makers drop products as EU law sows chaos

Nicola Osypka's German company has been selling medical devices used in surgery on newborn babies in Europe for decades, but new European Union rules have forced her to make tough decisions.

Reuters