BFH achieves ISO-13485 certification

The prerequisite for ISO-13485 certification is a comprehensive management system for the design and manufacture of medical devices. After all, ensuring the safety and health of patients is central, if not mandatory, for medical devices. Strict guidelines harmonized throughout Europe require continuous quality control and market surveillance. A certified quality management system that complies with ISO 13485 is therefore essential and in many cases only guarantees the approval and marketing of a medical device.

One, two or three?

"Active, invasive or implanted...?" These are terms of the three classes that need to be distinguished in medical devices. "We want all three!" said representatives of the "Institute for Human Centered Engineering" at the Bern University of Applied Sciences (BFH) to themselves, so that they can accompany product developments throughout the entire life cycle. In concrete terms: a stethoscope or a wheelchair have a low risk potential and are assigned to group 1. Group 2 includes products of medium to increased risk, such as contact lenses, hearing aids or X-ray machines. Cardiac pacemakers or knee prostheses, on the other hand, are classified in the 3rd class. These medical devices therefore have the highest risk potential.

First university in the whole of continental Europe

To ensure that medical products, regardless of their class, can be accompanied from the idea through research and development to technology transfer to industry, the "Institute for Human Centered Engineering HuCE" of the Bern University of Applied Sciences founded the "HuCE-microCert" group. In a unique process for a university, the "Institute for Human Centered Engineering HuCE" of the Bern University of Applied Sciences was the first university in the whole of continental Europe to obtain ISO-13485 certification. The conformity of the quality management system had to be proven in an elaborate evaluation procedure. The certificate makes the HuCE a valuable research and development partner for SMEs in medical technology.

Access to the EU market

In addition to a broad range of services for spin-offs, this certification also gives SMEs and industry easier access to the European market (CE marking) and a clear competitive advantage. This means that BFH's HuCE can now offer a complete package (including a qualified clean room for the production of small series) and act as a strong partner in the field of medical technology.

Source and further information: HuCE.bfh.ch