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.
Independent thinking on medical-device development
Where MedTech professionals think out loud.
Current commentary, professional discussion, regulatory developments, opinions and practical observations from the realities of developing medical devices.
Independent perspective based on 40+ years in safety-critical engineering and 12+ years in medical-device development.
Current commentary
Ideas, observations and arguments worth discussing.
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.
Browse by subject
The conversations shaping development.
Follow commentary across the connected technical, regulatory and organisational questions facing medical-device teams.
01
Design controls
Turn user needs into controlled requirements, verified outputs and defensible development evidence.
View commentary →02Risk management
Apply ISO 14971 as an active product-development discipline—not simply a collection of forms.
View commentary →03Software & SaMD
Practical lifecycle guidance for embedded, cloud, mobile and software-only medical devices.
View commentary →04Product cybersecurity
Integrate security into development, risk management, verification and post-market governance.
View commentary →05Verification & validation
Produce objective evidence that the product was built correctly—and is the right product.
View commentary →06Systems engineering
Define product purpose, architecture, interfaces, performance and traceability across disciplines.
View commentary →07Quality & regulatory
Connect QMS and regulatory expectations with proportionate practice and useful evidence.
View commentary →08Leadership & organisation
Build capable teams, effective governance and the conditions for reliable delivery.
View commentary →Choose what you need
Discuss. Learn. Apply.
MedTech.blog is one part of a connected set of independent resources from Paul Gardner.
MedTech.blog
Current commentary, regulatory developments, professional opinion and observations from practice.
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Experience.
Evidence.
Judgement.
Discussion.
Standards and regulations define expectations, but real projects still depend on interpretation, trade-offs, leadership and professional judgement.
MedTech.blog examines that space openly: what works, what fails, what changes—and what the industry should discuss next.
Read the editorial principles →