Medical Device Development Issue Log
This is a practical guide to building a issue log for a medical device development project — a register of problems that have occurred and need resolving, adapted to the realities of developing a regulated medical device.
What a Issue Log is
A issue log is a register of problems that have occurred and need resolving. For the full concept and how it works in general, see Issue 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 issue 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
- Issue description
- Priority and severity
- Owner
- Resolution and status
Medical Device Development-specific considerations
Tailor the issue 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 issue 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.