SGS (Belgium) Reviews & Capacity

After 1 year, we got comments about our intended use which was not accepted as a medical device. This was a horror after it costed us 1 year of hard work to hear that it is not even a medical device coz the intended use statement is not complete. No one wanted to help us out with our intended use and frustrating part of that it was just someone’s opinion.

ISO 9001. ISO 13485 (MDSAP) and CE (MDD) certification for 9 years in my previous company. Stopped and went to another NoBo this year.

We had troubles with our techdoc review some years ago, could not agree with the reviewer who was very picky. He gave no warning that we were exceeding the max review time of 6 months and our CE was suspended, so we could not CE label our products anymore (and sell). Image what this meant for us. Any NC they bring up, takes extra time from them. They obviously bill that. Having many NC’s is also very costly.

Communication was sometimes very difficult. Never clear answers. Two years ago they said they would be MDR designated soon. Last year the same. I think they were only designated recently.