On July 24, 2023, MBI successfully passed the BSI MDSAP Quality System Audit, which facilitates our product certification and sales process in Brazil, Canada, Japan and the United States. This success represents an excellent achievement in meeting the regulatory requirements of different countries.
MBI’s efforts are always focused on human health, and the acquisition of MDSAP will bring important advantages:
Rapid Market Entry: This enables us to meet the standards of the multinational medical device market at the same time, helping you to enter multiple markets more rapidly and capture business opportunities.
50% faster: By eliminating the need for local government quality system inspections, it is expected to save as much as half a year to a year, allowing for faster market entry.
Comprehensive Solutions: With the approval of this audit, MBI will be able to provide more diversified medical material solutions to meet the diversified demands of various countries and better respond to market changes.
Enhance Confidence: With the MDSAP-accredited quality system, the risk of MBI products in various markets will be minimized, allowing you to launch your products with greater confidence.
What is MDSAP?
MDSAP stands for “Medical Device Single Audit Program”, a multinational collaborative quality management system audit program that enables medical device manufacturers to undergo a single audit to meet the standards and regulatory requirements of the medical device market in multiple countries, including Brazil, Canada, the United States, Japan and Australia. Such audits can help manufacturers streamline the product certification and sales process, save time and resources, and help accelerate product launches in multiple markets.
The success of MBI in the global market not only demonstrates our position as a reliable partner, but also highlights our mission to put human health at the center of our endeavors. We will continue to strive to provide you with professional support, high quality solutions to achieve greater business success while contributing to the well-being of mankind.