Visia Lab has received notification of the achievement of the MDSAP (Medical Device Single Audit Program). This news impacts the sale of our devices in the five participating countries: USA, Canada, Japan, Australia and Brazil.
The MDSAP program allows bodies (Auditing Organizations – AO) recognized and accredited by the Regulatory Authorities of the five participating countries (U.S.A., Canada, Brazil, Japan and Australia) to conduct a single audit at the manufacturers of Medical Devices to verify that the latter satisfy the Quality System management requirements (GMP: Good Manufacturing Practice) of the reference countries.
Following the MDSAP audit model, the audits will be carried out for MDSAP, conducted consistently between certification bodies, in a logical and efficient manner, with attention to interactions between processes. These audits will be able to determine if there are systemic non-conformities of the quality management system.
The advantages of MDSAP certification are:- the ability to minimize disruptions to medical device manufacturers due to multiple regulatory controls
- provide reliable audit programs
- the reduction of times and costs
- the opportunity to exploit multiple international regulatory resources
- the access to multiple markets with a single audit
- to obtain greater consistency between certification bodies