MDSAP Achievement

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