We believe in working closely with clients to make their lives easier. Most senior people in medical device development are time poor with heavy demands on them and no let up. We realised that saving them time, during both the engagement and development process, is crucial to their own and a project’s success. So, we sat down with a number of clients and consultants to discuss their issues and map out the device development process across the MDR and FDA regulatory requirements.
The result is our new, ISO 13485, Medical Device Development Workflow which meets the requirements if ISO: 13485, FDA 21 CFR 820.30, ISO: 14971, and the regulatory bodies too whilst remaining lean and agile.
Take a look at our introductory video below, and get in touch if you would like to know more.