Human Factors, GMP & Struggling to Make a Cup of Tea!

By 26 March 2018 News No Comments
Human Factors Interactive Training

Medical Device training is often seen as a dry subject, but our recent experiences have proven it’s not always the case.

After working on various projects, we decided to engage Matthew Theobald of Three Circles and Mike Heald of Commala to deliver some bespoke training sessions on Human Factors, GMP and Design Controls.Human Factors Interactive Training

The latest session started with a brief introduction to Human Factors and just why they are so important to consider throughout the whole design and development process. 80% of errors in medical device use are due to Human Factors, such as poor design that doesn’t fully consider the intended user. Surprising when they are the people who the device is being created for in the first place!

The afternoon session was a much drier affair and covered GMP – Good Manufacturing Practice and 21 CFR Part 820 is not the most thrilling of subjects for anyone but after our recent transition to the latest ISO 9001 and ISO 13485 standards we were already confident our systems are compliant and meet the needs of the medical device industry. However, we can never know it all, using short, sharp awareness training means even drier subjects can still remain interesting and fun in the right environment.

Using external consultants for subjects like GMP & HFE means it’s easy to upskill new team members, keep at the forefront of the latest regulatory requirements and keep your team engaged.

Overall the training day was a huge success for all involved and has massively helped everyone when it comes to designing and developing products. If you want to know a little more about using Human Factors in medical device development, our approach to developing a design team or accessing some of our expertise then please get in touch.

Click here for more information on Human Factors & Medical Devices.

Click here for more information on Documentation Processes.

Click here for more guidance on applying Human Factors to Medical Devices.

GMP Training SessionHuman Factors Training Session