EU MDR / IVDR
EU regulations on medical devices and in-vitro diagnostics — clinical, technical, and increasingly cybersecurity requirements.
Manufacturers, authorised representatives, importers, and distributors of medical devices and IVDs in the EU.
Continuous evidence pipeline available; audit support included for all customers.
What MDR / IVDR actually requires.
These are the obligations a regulated entity owes — the things an assessor or supervisor will ask about.
Cybersecurity per MDCG 2019-16 Rev 1 (MDR) and equivalent guidance for IVDR.
Risk management to ISO 14971 incorporating cybersecurity.
Software life-cycle to IEC 62304 and risk management to IEC TIR 60601-4-5 where applicable.
Post-market surveillance and vigilance, including cybersecurity incident handling.
Unique Device Identification (UDI) and EUDAMED registration.
Pre-mapped controls. Continuous evidence.
Each requirement above is bound to live telemetry — not screenshots. The mapping below is what your auditor or regulator sees.
Software bill of materials and component lifecycle tracking for IEC 62304.
MDCG 2019-16 control crosswalk with continuous evidence.
Vigilance reporting workflow with EUDAMED-compatible export.
Artifacts your auditor accepts.
Each evidence artifact is signed and timestamped. Auditors can verify integrity without trusting Safeguard.
MDCG 2019-16 cybersecurity package.
Software lifecycle records per IEC 62304.
Post-market cybersecurity surveillance reports.
One evidence base. Many regulators.
These frameworks share substantial control overlap with MDR / IVDR. Customers running one assessment typically satisfy the others with the same evidence base.
HIPAA / HITECH
North America
Privacy, security, and breach notification rules for Protected Health Information (PHI) in the United States.
ISO/IEC 27001:2022
Cross-jurisdictional
The global Information Security Management System standard, updated in 2022 with 93 Annex A controls in four themes.
IEC 62443
Cross-jurisdictional
The industrial automation and control systems security standard family — the OT equivalent of ISO 27001.
Ready for MDR / IVDR?
Bring the framework. We'll walk the controls with you — section by section, evidence packet by evidence packet, with the regulators you actually have to answer to.