MDSAP stands for Medical Device Single Audit Program, which conducts a single audit for a medical device manufacturer's quality management system. This audit aims to ensure that the regulatory standard's numerous requirements are met. Auditing bodies or auditing organizations, such as the BSI, conduct the audits. The governing authorities have given these auditing bodies permission to conduct audits by MDSAP standards. MDSAP is a procedure that allows medical device manufacturers to be assessed once for conformity with standard and regulatory criteria in five medical device markets or locales, including the United States, Australia, Japan, Canada, and Brazil.
The primary purpose of this audit program, is to use regulatory resources to efficiently administer and sustain single audit programs that focus on medical device makers' overall surveillance.
MDSAP was created by officials from the TGA (Australian Therapeutic Goods Administration), the ANVISA (Agência Nacional de Vigilância Sanitária) of Brazil, Health Canada, the FDA (Food and Drug Administration) of the United States, and MHLW/PMDA. Regulatory agencies that participate in MDSAP programs are usually partners on an equal footing. Other regulatory agencies may also choose to engage in MDSAP projects. Official observers for the MDSAP, RAC (Regulatory Authority Council), and the SME (Subject Matter Experts) group, are usually the WHO (World Health Organization) and the EU (European Union).
We have Private Training available for more than 5 people from an organization. This training is provided at your location.
Consulting, Implementation & Coaching
Click here to know how Omnex can help you with Consulting, Implementation, & Coaching support for MDSAP.