Medical Device Development Assumptions Log
This is a practical guide to building a assumptions log for a medical device development project — a register of the assumptions the plan depends on, to be validated, adapted to the realities of developing a regulated medical device.
What a Assumptions Log is
A assumptions log is a register of the assumptions the plan depends on, to be validated. For the full concept and how it works in general, see Project Assumption. 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 assumptions 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
- Assumption
- Impact if wrong
- Owner
- Validation status
Medical Device Development-specific considerations
Tailor the assumptions 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 assumptions 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.