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.
Engineering field guide · Edition 1.0
Developing and Manufacturing Medical Devices for C-Suite and Non-Technical Leadership
A plain-language executive guide to the business system behind safe, compliant and commercially sustainable medical-device development.
What you will learn
A practical route through the lifecycle
- Why regulated development changes executive responsibilities
- Which decisions and evidence require leadership attention
- How culture, resourcing and governance influence product risk
Inside the guide
Key areas covered
- Executive leadership and the medical-device business model
- Quality-system foundations and governance
- Product strategy, portfolio and lifecycle decisions
- Evidence-based milestones and design controls
- Market access, manufacturing and supply-chain resilience
- Complaints, vigilance, change and executive review
Connected knowledge