Three Circles

Human Factors & Design Controls

Human Factors & Design Controls

Human Factors is key to your success in Medical Device Development.  As a recognised device development discipline, Human Factors should follow a clearly defined methodology.   If you are struggling to get to grips with incorporating Human Factors processes into your...

Successful medical devices have great Project Management!

Successful medical devices have great Project Management!

Significant project delays are often experienced when activities fall out of sync and people become blinkered, rushing to finish their goals first and missing sight of the big picture. Having a Device Development Strategy with a clear Plan matters, a lot. When setting...

Why  Quality Management matters more today than ever before

Why Quality Management matters more today than ever before

The importance of quality in medical device development is set to rise because: More complex and innovative devices are being created, and user environments are evolving, with increasing emphasis for use of devices and therapies in the home; there is a high potential...

Medical Device Risk Management

Medical Device Risk Management

Risk occurs in all our lives, it’s a part of our everyday living. To minimise the threats from risk and maximise their potential we need to manage our risks; this equally applies to the field of medical device development.  By implementing a risk management process,...