Following our successful transition in June to the latest 2016 revision of ISO13485, we were certified in November for a further 3 years for our client services in research, design, engineering, pre-production manufacture, verification and validation.Together with earlier system migration to satisfy 21 CFR Part 820, this certification enables us to conduct and deliver work that will be compliant well before the transition deadline in 2019. Certification by PDD to the latest 2016 revision also reduces the burden of subcontractor management placed upon companies by regulatory authorities.
The quality of our design and documentation is the subject of frequent and significant positive feedback by clients, some of whom are working towards the latest standards themselves and are able to be guided by our leading-edge design methodology and lean quality techniques.
Safety compliances are widely understood to be pre-requisites but these are not our sole focus: unless designs deliver improved treatment outcomes from inventive technology and delight professionals and patients with optimised usability they’re unlikely to succeed in the market. Our quality systems are designed to support such innovation.