What is Medical Safety Design?

Medical products must pass a usability engineering process and risk management process that is compliant to standards. We provide service from the initial product idea to continuous improvement.

Until recently, usability has "only" been a sales argument. The collateral standard DIN EN 60601-1-6 an EN 62366, however, requires the manufacturers of medical devices to assume a new duty: The measures for more usability must pass a usability engineering cycle and be documented in a usability file. Additionally, a risk management file must be prepared.

The experts for risk management and usability teamed up to make your product usable and safe. The employees of UID and c&m offer you an extensive range of services:

• We consult you on the usability engineering process and design your product according to usability criteria
• We carry out risk management according to ISO 14971:2007
• We prepare the accompanying and final documentation of the usability engineering process in a usability engineering file according to DIN EN 60601-1-6 (DIN EN 62366)
• We prepare your risk management file according to ISO 14971:2007
• We integrate the results of the clinical evaluation in our documentation