Medical Device Development Decision Log
This is a practical guide to building a decision log for a medical device development project — a record of the key decisions made, by whom and why, adapted to the realities of developing a regulated medical device.
What a Decision Log is
A decision log is a record of the key decisions made, by whom and why. For the full concept and how it works in general, see Decision 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 decision 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
- Decision
- Date and owner
- Rationale
- Alternatives considered
- Impact
Medical Device Development-specific considerations
Tailor the decision 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 decision 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.