Auditing and monitoring the manufacturing of medical devices to improve their safety and Quality

Aegis LifeSciences has successfully obtained the MDSAP certification proving its consistency and growth aligning with the best Quality management systems for Medical device manufacturing.

The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the lMDRf identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).

The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

International partners that are participating in the MDSAP include:

MDSAP Members

Therapeutic Goods Administration of Australia Brazil’s Agência Nacional de Vigilância Sanitària

Health Canada

Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency

U.S. Food and Drug Administration MDSAP Official Observers:

European Union (EU)

United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA)

The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme MDSAP Affiliate Members:

Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) Ministry of Health of Israel (NEW)

Republic of Korea’s Ministry of Food and Drug Safety Singapore’s Health Sciences Authority (HSA)

Contact Aegis Lifesciences for more information: