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ac.biomed gains new quality certification and demonstrates a manufacturer’s mindset

In December 2019, ac.biomed has successfully been audited according to DIN EN ISO 13485:2016. “This was the logical next step in expressing our commitment towards our clients from the medical devices industry”, managing director Peter Knipp claims. “We know who our clients are and what they expect!” Such, ac.biomed had decided to have its own quality system comply with the same requirements that the industry for medical devices applies. ISO 13485:2016 asks much more control over suppliers if they are not certified to the same level. Through the advanced certification, ac.biomed does not only support its clients by releasing them from their obligation to do supplier audits, but it is also a tremendous advantage to the team, expressing the spirit of feeling responsibility for our products and services. Our services are part of the life cycle activities for life-saving medical devices. Testing is not just an isolated task. Quality Manager Sandra Fiehe concludes: “We are now even more capable of supporting our client’s regulatory applications, and I believe we are well prepared for the European MDR, which is a huge challenge to the industry.”