Having undertaken the effort to include MDSAP in their quality management systems, Art Optical has obtained MDSAP certification.
Recognizing that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety on an international scale, the International Medical Device Regulators Forum (IMDRF) initiated the preparation for the Medical Device Single Audit Program (MDSAP). In addition to the USA, the countries participating in this comprehensive approach to quality system auditing include: Australia, Brazil, Canada and Japan. In contrast to the other partners in the program where participation is voluntary, beginning January 1, 2019, MDSAP became mandatory for Class II, III, and IV medical devices in Canada. Art Optical successfully completed the certification assessment in July of 2018, but due to regulatory backlog, was only recently awarded the official certification notice.
As an MDSAP certified device maker, Art Optical’s eye care practitioner customers in Canada can rest assured that the company can continue to service their specialty lens needs within compliance to the MDSAP standard. Art Optical is also registered with Health Canada, and maintains ISO 13485 certification.
To be compliant with this most rigorous quality standard also allows the company to further expand their global reach.
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