The International Standards Organization (ISO) first published ISO 13485 in 1996 and later produced a revised version known as ISO 13485:2016. The latest document institutes an international standard for the establishment and maintenance of quality management systems at medical device companies that
Compliance with the latest ISO 13485 standards provides full-circle benefits for medical device manufacturers. Here are just a few reasons why your medical device company will benefit from establishing compliance with this global quality standard for medical device companies:
ISO 13485 is a voluntary standard - firms that conform to the standard can benefit from certain perks, such as being able to sell medical devices in the European Union, but compliance with ISO 13485 is ultimately a voluntary decision that medical device companies make.
On the other hand, medical device companies that sell their products in the United States must comply with the FDA's 21 CFR Part 820, a legal mandate for medical device quality systems. If your medical device company is in the United States, an FDA inspection that results in observed violations or a warning letter could lead to civil prosecution for failure to comply with the appropriate regulations.
Learn more about the difference between standards and regulations here.
Greenlight Guru’s Quality Management Software platform has been specially tailored for the medical device industry to facilitate compliance with ISO 13485:2016 and help med-tech companies reduce time-to-market for their products. A paperless repository of all your quality procedures and compliance documentation ensures that both ISO and FDA audits finish smoothly and successfully.