ISO 13485 - MDSAP
Assessment of a company’s quality system under the MDSAP program leverages the ISO 13485:2016 as the primary standard. In addition, based on customer requests specific participating country requirements are included in the assessment.
The MDSAP allows recognized auditing organizations to conduct a single regulatory audit of medical device manufacturers that satisfy the relevant requirements of the regulatory authorities participating in the program. Currently Canada, USA, Brazil, Japan and Australia participate in the MDSAP program.
EN ISO 13485
EN ISO 13485:2016 – Coligne quality management system certificate.
ISO 13485:2016 specifies requirements for a quality management system where organizations need to demonstrate their ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
A free read-only version of the complete EN ISO 13485:2016 standard is available here.
EC-Certificate – Full Coligne quality assurance system certificate.
Sales of medical devices in the European Union (EU) require CE marking of the product. CE marking indicates that medical devices comply with the applicable EU regulations and enables the commercialization of products in 32 European countries. Medical device manufacturer are responsible for maintaining regulatory compliance and securing CE marking for all their products.