Rethinking compliance work.

Hover a bubble to see what it covers.

MDR (EU 2017/745, EU regulation)

The EU Medical Device Regulation. Technical documentation, clinical evaluation, post-market surveillance and CE marking.

FDA (21 CFR, US · FDA)

The US Food and Drug Administration. Device classification, premarket submissions and the device rules under Title 21.

ISO 13485 (Quality management, Standard)

Quality management systems for medical devices. The backbone of both CE marking and the FDA QMSR.

IVDR (EU 2017/746, EU regulation)

The EU regulation for in vitro diagnostic devices, with risk classes A to D and far wider notified body involvement.

QMSR (21 CFR 820, US · FDA)

The FDA Quality Management System Regulation, which incorporates ISO 13485 by reference.

ISO 14971 (Risk management, Standard)

Risk management across the device lifecycle: hazards, risk controls and the evaluation of residual risk.

Part 11 (21 CFR Part 11, US · FDA)

Electronic records and electronic signatures: audit trails, access control and signature binding.

GDPR (EU 2016/679, EU regulation)

EU data protection for the personal and health data your device and its documentation handle.

IEC 62304 (Software lifecycle, Standard)

Lifecycle processes for medical device software and software as a medical device.

510(k) (Premarket notification, US · FDA)

Clearance by showing substantial equivalence to a legally marketed predicate device.

AI Act (EU 2024/1689, EU regulation)

EU rules for AI systems. Medical devices that use AI are generally classed as high-risk.

IEC 60601-1 (Electrical safety, Standard)

Basic safety and essential performance of medical electrical equipment.

PMA (Premarket approval, US · FDA)

Approval route for Class III devices, backed by clinical evidence of safety and effectiveness.

IEC 62366-1 (Usability, Standard)

Usability engineering: making sure the device can be used safely by its intended users.

ISO 10993 (Biocompatibility, Standard)

Biological evaluation of devices that come into contact with the body.

De Novo (Novel devices, US · FDA)

Classification route for novel low-to-moderate risk devices that have no predicate.

MDCG (Guidance, EU regulation)

Guidance from the Medical Device Coordination Group on how to interpret MDR and IVDR.

EUDAMED (EU database, EU regulation)

The EU database for devices, UDI, certificates, vigilance and clinical investigations.

524B (FDA cybersecurity, US · FDA)

Cybersecurity requirements for cyber devices in FDA premarket submissions.