Notified Bodies are no longer fighting for your attention – you need to fight for their attention!
Suggested Screening Questions
– Will my QS lead auditor also be my lead Technical File (CE) project manager/reviewer?
– Are any of your auditors contractors (vs. employees)?
– Who will be my QS lead auditor? Can you provide their CV (or bio)? May I speak to him/her?
– Who will be my CE Technical File lead auditor? Can you provide their CV (or bio)? May I speak to him/her?
– Is your CE lead auditor a project manager who “subcontracts” the review of the various Tech File subjects, or do they personally perform the detailed technical reviews? If the former, who else is on the review team?
– Who is our lead reviewer for clinical evaluation data? Employee/contractor? Practicing physician? Has enough time? What is their process?
– Where do my auditors live? USA? Europe? Travel costs extra or built in?
– What is your process for secondary review of audit reports submitted by auditors? What is turn time? (see Note 1)
– How often are surveillance audits? (expect annual, dread semi-annual)
– What is the process for review/approval of Change Notifications? What is the cost? Turn time?
– What if I don’t like my lead auditors down the road?
Questions for Candidate Auditors (see Note 2)
Note 2 – You are not just hiring a NB; you are hiring your lead auditors and perhaps a team of reviewers. You may be able to shop around for auditors within a given NB but you may end up liking the one who lives 9 time zones away (communication more challenging, travel costs greater).
Other Points To Consider / Reminders
- Registration Audit Timeliness
– If scheduling registration audit today, how long into the future will the audit be scheduled?
-Is this consistent with when your company will be ready for audit?
- Interview Pre-Assigned Quality System Lead Auditor
- Interview Pre-Assigned Technical File Lead Reviewer
- Discuss CE Marking Pathway
– Full QA System? (typical, recommended)
– Agree on device classification
– Clinical Evaluation Plan (literature, clinical investigation, combined)
- Direct Costs (prepare comparison spreadsheet)
– QMS Registration Audit Fee (Goal: EN ISO 13485 and MDD Annex II.3 certificate)
– Technical File Review/Approval Fee (Goal: CE Certificate for product category)
– QMS Surveillance Audit Fee
– QMS Renewal Audit Fee (typically every 3 years after registration)
– Fee Structure, Auditor Day Rate, Certificate Fees, etc.
– QMS Surveillance Audit frequency? (typically 2 per cycle)