openregulatory / notified-body-survey-data

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

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.