
In our business, a verification and validation period for the finished product is a must, but how to make this final V&V more lightweight without compromising product quality and safety? AAMI TIR45 provides some answers for software, but less has been written about agility in system and hardware development for medical devices.
Are we on the right track with SAFe? We have now asked our people three times if they would recommend the new way of working to a friend or colleague. So far, the answers have been more positive after each increment. I’ll let you guess the scale.