Bioexcelife
Design verification is one of the most critical steps in medical device development — and one of the most misunderstood. Even seasoned manufacturers face setbacks during this stage, leading to rework, timeline extensions, budget overruns, and regulatory delays.
Understanding and avoiding these pitfalls can save months of effort and significantly increase your chances of a smooth CE marking, FDA submission, or ISO 13485 audit.
Pitfall #1: Vague or Non-Measurable Design Inputs
The most common mistake in verification is starting with poorly defined design inputs. If requirements are unclear or subjective, verification becomes nearly impossible.
Example:
❌ “The catheter should be flexible.”
✔️ “The catheter must have a minimum bend radius ≤ X mm measured per ISO 11070.”
Why this matters:
- Measurable inputs ensure objective testing.
- Regulatory bodies expect traceable, quantifiable requirements.
- Clear inputs reduce back-and-forth with QA/RA teams.
Pitfall #2: Unclear or Missing Acceptance Criteria
Verification is meaningless without defined acceptance limits.
Ambiguous criteria make results subjective, which can lead to major non-conformities during audits or reviews.
Regulators expect:
- Predefined limits
- Test methods aligned with standards
- Pass/fail justification
- Reference to risk mitigations
Without these, verification becomes an opinion — not evidence.
Pitfall #3: Late QA/RA Involvement
Verification is not just an R&D activity — it is a cross-functional responsibility.
When QA/RA joins late:
- Risk controls may not align with test plans
- Standards may be missed
- Documentation gaps appear
- Verification must be revised or repeated
Best practice:
Engage QA/RA early to ensure alignment with:
- ISO 13485 design control requirements
- ISO 14971 risk management
- IEC/ISO performance standards
- Regulatory submission expectations
This reduces redesigns and prevents costly late-stage rework.
Pitfall #4: Inadequate Documentation
Many verification activities fail not because the test was wrong but because the documentation was incomplete.
Typical documentation gaps include:
- Missing calibration certificates
- Incomplete raw data
- Missing operator signatures
- No photos or test setup evidence
- Missing environmental conditions
- Incorrect test equipment listed
Remember:
Regulators don’t see the test — they see the documentation.
If it’s not documented, it didn’t happen.
Pitfall #5: Treating Verification as a One-Time Event
Design verification is not a single milestone. It must be updated throughout the device lifecycle:
- After design changes
- After CAPAs
- After failures or complaints
- During risk file updates
- During new clinical or user feedback
If verification doesn’t evolve with design changes, your DHF and technical file will show inconsistencies — a red flag for Notified Bodies and the FDA.
Final Takeaway
Avoiding these pitfalls requires a combination of clear requirements, robust planning, traceability, and strong documentation. When handled correctly, verification becomes a powerful tool that:
- Reduces regulatory delays
- Strengthens your DHF
- Improves device safety and performance
- Boosts confidence with Notified Bodies and auditors
Need Expert Support?
Bioexcel’s verification specialists can:
✔ Review and audit your verification protocols
✔ Identify compliance gaps before NB or FDA review
✔ Strengthen your traceability and documentation
✔ Align your verification plan with ISO 13485 & ISO 14971
Let us help you avoid costly delays and move forward confidently toward regulatory approval.
