We’re proud to have been awarded ISO 13485:2016 certification- the international standard for medical device quality management in Europe.
As part of our long term commitment to design quality and to meet the growing needs of our medical clients, we’re pleased to have been awarded certification to ISO 13485:2016 for the internationally recognised standard for medical device quality management.
There are many strict regulatory requirements within the healthcare sector with regards to product design to ensure product safety and efficacy. ISO 13485:2016 defines these requirements in Europe and we have designed our quality management systems to be compliant with this standard as well as ISO 9001:2015, which is based on a number of quality management principles including a strong customer focus, motivation and implication of top management, a controlled process approach and continual improvement. Working together, these principles which are intrinsic in our quality management systems, ensure our clients have the best quality products and services, which in turn brings many business benefits.
Importantly, this new certification means that Design Reality can deliver regulatory compliant development programmes for medical devices to healthcare companies in Europe. Working with a compliant partner like Design Reality will enable healthcare and medical device companies to minimise the time and cost associated with integrating an external development partner into their own quality management systems. It also means that the design process can proceed more rapidly, and that quality management is seamless throughout every stage of the product design process.
For medical start-ups, we can provide an outsourced product development service with an integrated management programme. This will ensure that, working closely with clients, we can deliver a complete product design service with all the necessary technical filings in Europe.
If you’re interested in speaking to us about the design of a medical device, and would like to take advantage of our ISO 13485: 2016 certification, please get in touch
We’re also certified to the ISO 9001:2015 standard- find out how ISO standards help our clients >