Notified Body Selection Advice

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)

– Do you enjoy your work? Are you burned out?
– What types of products do you like to work on?
– Do you agree with our assessment of the device classification per the Directive? (tell them intended use, Rule #, classification)
– What is the relationship between your work and the work of the “other” lead auditor? Good reasons to communicate with each other? Or are you completely independent.
– For single QS/CE auditors: Are there ways to leverage your intimate knowledge of our QS to reduce the need for Change Notifications down the road?
– Clinical Evaluation: Explain how clinical evaluation data is reviewed. What should we be looking out for?
– Explain how the secondary review process works at headquarters for your audit reports. How long does it take?
Note 1 – DEKRA historically has had a “peer review” followed by certification management review. Everyone will minimally have certification management review. Turn times can vary depending on work load and resources of each NB.

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)

Related Posts
Notified Body Short List 
Notified Body Sleuthing

Published by Sam Lazzara

Sam Lazzara is a Biomedical Engineer (MS Case Western, BS Brown University) and Certified Biomedical Auditor with 30+ years medical device experience. Sam’s systems and documents have delighted dozens of regulatory auditors from the United States FDA, the California Department of Health, and a flock of European Notified Bodies. He has guided quality system implementation for over 20 firms, leading to third-party certification and government approvals. A medical device start-up specialist, Sam provides state-of-the-art solutions tailored to the needs of each client. He mentors clients on all aspects of quality assurance and regulatory affairs. Sam gets particularly excited about design control, risk management, and post-market surveillance.

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