Are you a medical device manufacturer? According to the new Regulation (EC) 2017/745 on medical devices (MDR), medical device manufacturers must demonstrate to notified bodies that all critical suppliers conform with the ISO 13485 standard covering quality management...
After more than a year of dedicated effort and nearly 4.000 hours of preparation, we are proud to announce that we have received the globally recognised ISO 13485:2016 certification from BSI under certificate number MD725842. We chose BSI as our certification partner...