About Paul Gardner
Paul Gardner is an executive engineering leader and medical-device consultant with more than 40 years’ experience in safety-critical engineering and more than 12 years in medical-device development.
His experience spans connected devices, embedded and cloud software, design controls, risk management, verification and validation, product cybersecurity, regulatory submissions and the transformation of engineering organisations.
The purpose of this site
MedTech.blog explores the difficult, current and sometimes uncomfortable questions that arise when regulatory expectations meet real product development. It provides a place for professional judgement, lessons from practice and informed opinion—not only evergreen instruction.
For structured learning pathways, role-specific guides and durable reference material, visit MedTech Learning. For help applying these ideas to a product or organisation, visit PG Consulting.
Editorial principles
- Distinguish facts, regulatory requirements and professional opinion.
- Explain why a development issue matters in practice.
- Connect technical decisions to patient, product and business consequences.
- Welcome thoughtful professional discussion and alternative perspectives.
- Date and review time-sensitive regulatory commentary.