We offer a complete solution for developing and manufacturing medical products. We work to ISO 13485 and offer access to a team of Medical Device Professionals who work both within industry and on behalf of the Notified Bodies.
Highly structured and fully documented
Our bespoke in-house software ensures that every stage of each design project is tracked and documented thoroughly. We are ISO 9001:2015 and ISO 13485:2016 certified.
Regular internal and external auditing ensures we are always up-to-date with standards required, while continuously streamlining these processes for the benefit of our clients.
An informed approach
The development of any medical device requires a strong foundation of knowledge and planning from the outset.
It is our broad range of skillsets, medical device experts and our own manufacturing capabilities that allow us to offer clients the support and direction they need progress seamlessly to market.
Certified without delay
For companies in medical device development we offer a turnkey solution through design, manufacture and regulatory compliance.
This single platform of expertise is achieved through collaboration with our medical auditors, and IKONYX (3fD’s manufacturing facility) and is recognised by the Notified Bodies that carry out the certification for your product.
Not just appropriate... Truly desirable
As with any product, a medical device has to be appropriate. But we aren’t here to just meet the obvious needs, we are here to find new ones. The look, feel and overall user experience of your product is the difference between it becoming a market competitor and a market leader.