MEDICAL DEVICE CERTIFICATIONS
Reduce risk & Control processes
Medical Device Directive
The Medical Device Directive 93/42/EEC (MDD) was established on June 14, 1998 and later amended on September 5, 2007. This directive became mandatory on March 21, 2010. The intent of the directive was to harmonize the regulatory requirements for medical devices with the European Union.
ISO 13485
Medical Devices
ISO 13485:2016 is an internationally recognized quality standard that encompasses specific requirements of an organization to demonstrate its ability to provide medical devices and related services that consistently meet customer as well as regulatory requirements. ISO 13485 is ...
MDSAP
Meet multiple requirements with a single audit.
ISO 15378
Primary packaging materials for medicinal products
Pharmaceutical companies need to ensure that their own supplier audits fulfill relevant legal requirements. This is why when selecting a supplier of packaging materials, particular attention needs to be paid to their ability to fulfill current GMP ...