Standards Council of Canada (SCC) has confirmed that Lloyd’s Register (LR) is now accredited to ISO 13485:2016 and ISO 13485:2016 under Canadian Medical Device Conformity Assessment System (CMDCAS) requirements, following a recent transition audit.
Lloyd’s Register Quality Assurance, Inc. - the accredited body for ISO 13485 within the LR Group in North America - can now deliver certification services to the latest version of the international medical devices quality management system standard, which is aligned to the global regulatory environment. In December 2015, Health Canada confirmed that the Medical Device Single Audit Program (MDSAP) will replace CMDCAS; from January 2019, only MDSAP certificates will be accepted.
Susan Mecca, Medical Devices Senior Technical Manager for LR in North America, commented, “We are delighted to achieve accreditation to the latest version of ISO 13485. The latest version of the standard helps organisations to improve their performance and to make their management systems more robust. Medical Devices organisations have until January 2019 to migrate to MDSAP and March 2019 to transition to ISO 13485 and we have a wealth of resources and training to support you on your journey.”
With all the major ISO standards being revised, we are at the forefront of communicating the changes. We offer a range of assessment services as well public and in-house training courses, all aimed at helping to ensure that organisations worldwide have a smooth transition to the new standards.