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OpenRegulatory Notified Body Survey Data

This is the data of our notified body survey, gathering anonymous "Amazon reviews" from medical device on notified bodies (those are the institutions which audit them, and it's often a suboptimal process).

You can view a nicely-rendered version of this data on our Notified Body Reviews page. There's also the announcement blog post which provides a more in-depth explanation of why we're doing this.

Some quick notes on data types and our fancy preprocessing (spoiler: it's me, sitting in front of my computer at night, editing a spreadsheet):

  • Company names were removed - this is anonymized data after all.
  • Wait time durations (for QMS / Techdoc audit) were initially a string field but were now converted to an integer with the unit being months.
  • If a wait time range would be entered, we would take the average value. "3-5 months" would become "4 months", while "2-3 months" would become "2 months" - we're nice people after all and will give the notified body the benefit of the doubt here.

Fields and Data Types

field data type example comment
submission_date date 2022-02-28 Date of submission.
notified_body string bsi-netherlands Name and country of the notified body.
company_size enum (string) 50-249 Possible values: 1-9, 10-49, 50-249, >=250.
offer_received boolean TRUE Whether the company received an offer. Depending on your csv parser, booleans might end up being strings.
offer_accepted boolean TRUE Whether the company accepted the offer.
qms_done boolean FALSE Is the QMS audit done?
techdoc_done boolean FALSE Is the Techdoc audit done?
stage string Only QMS audit blabla Further elaboration on the current audit stage.
wait_time_qms_audit integer 6 Wait time for QMS audit in months.
wait_time_qms_certificate integer 3 Wait time for QMS certificate after successful audit in months.
wait_time_techdoc_audit integer 12 Wait time for Techdoc audit in months.
wait_time_techdoc_certificate integer 6 Wait time for Techdoc certificate in months.
cost string About 20.000€ Cost and explanation.
comment_duration_cost string Response time is terrible Comment on duration and cost.
rating_overall_experience integer 3 Rating of overall experience (stars, 1 = very bad, 5 = very good)
would_choose_again boolean TRUE Whether the company would choose this notified body again.
rating_well_organized_responsive integer 3 Rating of how well organized and responsive they are (stars, 1 = very bad, 5 = very good)
rating_regulatory_pragmatism integer 3 Rating of how pragmatic they are (stars, 1 = very bad, 5 = very good)
rating_technical_competence integer 3 Rating of how technically competent they are (stars, 1 = very bad, 5 = very good)
comment string skeptical of GDrive Generic comment.
comment_why_not_customer string no capacity Comment on why the company didn't become a customer of the NB.


Anonymous review of notified bodies by medical device manufacturers, in a CSV file.