Notified Body Selection Advice
Sam Lazzara Resume LinkedIn Profile Documents Services Schedule Call +1 510 397 9739 sam@lazzara.net Related Posts Notified Body Short List Notified Body Sleuthing 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 ext