August 26, 2025
Review by company with 10-49 people
QMS audit done
Techdoc audit done
- Overall experience
- Well-organized / responsive
- Regulatory pragmatism
- Technical competence
- Wait time before QMS audit
- 3 Months
- Wait time before Techdoc audit
- 18 Months
- Wait time before QMS certificate
- 36 Months
- Wait time before Techdoc certificate
- 36 Months
- Approx. cost (EUR)
- 100,000 €
As a medical device manufacturer operating under EU MDR 2017/745, we have been engaged with SGS since 2022. This review reflects our experience with their services, professionalism, and regulatory competence.
We submitted our application in June 2022 and formally signed the contract with SGS in October 2022. Our ISO 13485:2016 certification process began with the Stage I audit in January 2023, followed by the Stage II audit in June 2023. However, after the completion of these audits, we experienced a delay of 13 months before a date was assigned for our technical file review.
Just before the review commenced, we were informed that the file was being classified as covering a dual-purpose device, and as a result, additional charges were applied to the review process.
Following our initial review (11.5 Man-days), we encountered several instances where the reviewers appeared to have overlooked information that was already clearly addressed within our technical file. This gave the impression of unnecessary repetition, which in turn seemed like a deliberate effort to increase billing.
For example;
During the initial review, the reviewer requested a PSUR Plan—a document that is neither defined in the EU MDR nor included in their own checklist—while simultaneously marking the Post-Market Surveillance (PMS) Plan as Not Applicable. As a result, the entire PMS Plan was effectively disregarded during the review.
In October, 2024 we submitted our files for a follow up review to which we were assigned a date in Jan, 2025, this was invoiced at an increase costs more than agreed up on in our contract which states "SGS reserves the right to make changes". The total number of man-days charged for a followup were 6.5 Man-days.
During the follow-up review, we faced significant challenges. A single oversight in updating a revision number resulted in 16 Major Non-Conformities being raised against a file of approximately 15 pages. The process appeared inconsistent, as revision number issues were cited even on documents that had already been updated and formally acknowledged by the reviewer within their own technical documentation review checklist. Again resulting in a full man-day.
In addition we were billed 1.5 Man-days for 3 PIC (Potential Issues to be Clarified) which were cleared with less than an A4 size document. We filled a complaint with SGS local office and Belgium office to which there was no action taken.
Finally, on 3rd July 2025, we were informed by our local office that our technical file had been completed and recommended for certification. Since then, however, we have been waiting for the certificate to be issued, with no clear indication of when it will actually be delivered.
In my experience of running a business for nearly two decades, we have never encountered such an unethical approach—where costs were increased during the initial stages and delays were caused by the Notified Body’s own actions.
Working with SGS Belgium has at times felt less like a collaborative regulatory process and more like undue pressure. The unexpected imposition of additional charges, combined with delays and inconsistent reviews, created the impression of a system designed to exploit rather than support manufacturers striving for compliance. Instead of providing clarity and constructive feedback, the approach often felt coercive, leaving us with little choice but to accept terms in order to avoid further setbacks in our certification timeline.
We would strongly advise avoiding this Notified Body, as our experience has shown their performance to be far worse than even their existing reputation suggests.
We submitted our application in June 2022 and formally signed the contract with SGS in October 2022. Our ISO 13485:2016 certification process began with the Stage I audit in January 2023, followed by the Stage II audit in June 2023. However, after the completion of these audits, we experienced a delay of 13 months before a date was assigned for our technical file review.
Just before the review commenced, we were informed that the file was being classified as covering a dual-purpose device, and as a result, additional charges were applied to the review process.
Following our initial review (11.5 Man-days), we encountered several instances where the reviewers appeared to have overlooked information that was already clearly addressed within our technical file. This gave the impression of unnecessary repetition, which in turn seemed like a deliberate effort to increase billing.
For example;
During the initial review, the reviewer requested a PSUR Plan—a document that is neither defined in the EU MDR nor included in their own checklist—while simultaneously marking the Post-Market Surveillance (PMS) Plan as Not Applicable. As a result, the entire PMS Plan was effectively disregarded during the review.
In October, 2024 we submitted our files for a follow up review to which we were assigned a date in Jan, 2025, this was invoiced at an increase costs more than agreed up on in our contract which states "SGS reserves the right to make changes". The total number of man-days charged for a followup were 6.5 Man-days.
During the follow-up review, we faced significant challenges. A single oversight in updating a revision number resulted in 16 Major Non-Conformities being raised against a file of approximately 15 pages. The process appeared inconsistent, as revision number issues were cited even on documents that had already been updated and formally acknowledged by the reviewer within their own technical documentation review checklist. Again resulting in a full man-day.
In addition we were billed 1.5 Man-days for 3 PIC (Potential Issues to be Clarified) which were cleared with less than an A4 size document. We filled a complaint with SGS local office and Belgium office to which there was no action taken.
Finally, on 3rd July 2025, we were informed by our local office that our technical file had been completed and recommended for certification. Since then, however, we have been waiting for the certificate to be issued, with no clear indication of when it will actually be delivered.
In my experience of running a business for nearly two decades, we have never encountered such an unethical approach—where costs were increased during the initial stages and delays were caused by the Notified Body’s own actions.
Working with SGS Belgium has at times felt less like a collaborative regulatory process and more like undue pressure. The unexpected imposition of additional charges, combined with delays and inconsistent reviews, created the impression of a system designed to exploit rather than support manufacturers striving for compliance. Instead of providing clarity and constructive feedback, the approach often felt coercive, leaving us with little choice but to accept terms in order to avoid further setbacks in our certification timeline.
We would strongly advise avoiding this Notified Body, as our experience has shown their performance to be far worse than even their existing reputation suggests.