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.
| 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. |