Medical Device Development Change Log
This is a practical guide to building a change log for a medical device development project — a record of change requests and their decisions, adapted to the realities of developing a regulated medical device.
What a Change Log is
A change log is a record of change requests and their decisions. For the full concept and how it works in general, see Change Log. On a medical device development project it plays the same role, tuned to this kind of work.
Why it matters for a Medical Device Development project
Medical Device Development projects live or die on developing a regulated medical device. A well-built change log gives the team a shared, explicit reference for exactly that — reducing ambiguity, aligning stakeholders, and making problems visible early enough to act. Skipping it, or doing it generically, is how medical device development projects drift into avoidable delay and cost.
What to include
- Change ID and description
- Impact assessment
- Decision and date
- Updated baselines
Medical Device Development-specific considerations
Tailor the change log to the risks that most often derail medical device development projects:
- Regulatory approval (FDA/CE)
- Design verification
- Quality-system compliance
Example
On a real medical device development project, the change log would be shaped by developing a regulated medical device. In particular, it should explicitly account for the project’s biggest risks — regulatory approval (FDA/CE), design verification, quality-system compliance — rather than treating them as afterthoughts.