Quality & regulatory teams
Two complementary guides covering quality assurance, regulatory strategy, evidence, submissions and lifecycle governance.
Guide details →2 PDFs · 23 August 2026
Quality & regulatory teams
Development evidence, governance, standards strategy and submission readiness.
Downloadable field guides
Guidance written for your role
Risk managers
ISO 14971-centred risk management connected to engineering decisions, evidence and lifecycle governance.
Guide details →1 PDF · 23 August 2026
Articles
Related practical guidance
The practical guide to developing a medical device
An end-to-end view of medical-device development, from intended purpose and user needs through verification, validation, transfer and maintenance.
Design controls: from user need to objective evidence
How user needs, requirements, design outputs, risk controls, verification and validation form a coherent evidence chain.
Why an FMEA is not a complete product risk analysis
Understand where FMEA helps, what it misses and how to integrate it into a complete medical-device risk-management process.
IEC 62304 and the medical-device software lifecycle
A practical introduction to IEC 62304, software safety classification and the evidence created across development and maintenance.
Medical-device cybersecurity: an integrated lifecycle approach
How to integrate cybersecurity governance and evidence across the complete medical-device lifecycle.
Verification and validation: what is the difference?
A clear explanation of verification, validation and how both connect to user needs, design inputs and objective evidence.
Primary functions, essential performance and safety-related requirements
A practical framework for distinguishing device functions, essential performance, safety-related requirements and supporting quality attributes.
Building an audit-ready design history file
What makes development evidence coherent, reviewable and defensible before an audit or submission.