Wideblue achieve accreditation to ISO9001 and ISO13485

Wide Blue 01 August 2015

Wideblue are delighted to announce our recent accreditation to ISO9001 and ISO13485.

Although we are very familiar with the requirements of the Medical Device Directive (93/42/EEC), FDA requirements, new product CE marking, ISO9001 and ISO13485 and have in fact been designing products to these standards for many years, we can now announce our formal accreditation to the ISO 9001: 2008 and ISO 13485: 2003 quality standards.

After making the decision to implement the standards in January this year, we rewrote our quality system in March, followed up with an LRQA Stage 1 Audit in May and a final audit in June, achieving our full accreditation in August. This accreditation will allow us to more effectively integrate our customers’ new product development activities with our regulatory and CE marking activities.

Our full accreditation is applicable to the contract design and development of technology-based consumer, commercial, medical and scientific applications plus the contract development of technology-based medical devices.