CSA, Part 11 and QMSR: building a coherent software assurance approach
A practical approach to shared software assurance evidence, with clear regulatory boundaries and a worked calibration-system example.
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.
Which standards apply to an IVD medical device?
Why standards selection for an IVD must follow the complete system, its intended purpose and the consequences of an incorrect result.
Which standards does your medical device actually need?
Why a long standards list is not enough—and how intended purpose, harmonisation and product-specific evidence shape a defensible standards assessment.
AI! AI! Oh?
A playful but serious reflection on AI as assistant, reviewer and decision-maker—and why fluent answers still need evidence, judgement and accountability.
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.
Continue reading →MedTech Learning
Structured learning pathways, role-specific guides, standards explainers and downloadable resources.
Visit MedTech Learning →Medical Devices Done Right
Independent professional support for development, assurance, audit readiness and remediation.
Visit Medical Devices Done Right →The editorial lens
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 →