ISO13485 certification

“These are strange times” as many people say. Strange to some, and a disaster to others. The Corona pandemic kills people, shops, restaurants, and companies. So, we are not complaining, as we are still very much alive. We have merely a small set-back in our planning. The microbiological audit for the ISO13485 certification is delayed for the fourth time due to the Covid situation. Is this a disadvantage for you as a customer? No, not really, as we work according to ISO13485, and being certified is not a regulatory requirement. The process-validation takes time and by the time we will produce products, we will be certified.

A short explanation for those that are not familiar with the process of obtaining ISO13485 quality management certification. Vosfox Medical has to pass a stage 1, a stage II, and a microbiological audit. The first two stages were closed successfully, after two times cancelation of stage II audit. However, BSI, our notified body had to postpone the microbiological audit time and time again. This is partly due to a shortage of microbiology auditors. The audit is now planned for April this year. If you are interested in contract manufacturing or our other services, please contact us.

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