January 22, 2024 – Budapest Hungary
3DHISTECH, a global leader in digital pathology solutions, is proud to announce its successful completion of the Medical Device Single Audit Program (MDSAP) with two jurisdictions, Canada, and Australia. This certification demonstrates the company’s compliance with ISO 13485 standards and the specific regulatory requirements of participating countries, including Canada and Australia, opening doors for expanded distribution of its innovative products and services in these regions.
MDSAP is an international initiative designed to streamline regulatory audits for medical device manufacturers, allowing a single audit to satisfy requirements across multiple markets. With participating authorities in the United States, Canada, Brazil, Japan and Australia, the program ensures regulatory compliance while reducing the need for multiple audit, enabling manufacturers to focus on delivering advanced solutions to healthcare professionals worldwide.
“This milestone reflects 3DHISTECH’s commitment to quality and regulatory excellence,” said Dr. Béla Molnár, CEO of 3DHISTECH. “Achieving MDSAP certification not only reinforces our dedication to providing cutting-edge digital pathology solutions but also accelerates our ability to meet the needs of distributors and healthcare providers in Canada and Australia. We are excited to expand our reach and deliver innovative technologies to these critical markets.”
By meeting the stringent requirements of Health Canada and the Therapeutic Goods Administration (TGA) in Australia, 3DHISTECH is well-positioned to strengthen its partnerships with local distributors and expand access to its advanced whole slide imaging scanners, diagnostic software, and pathology solutions. This achievement marks a significant step forward for 3DHISTECH as it continues to advance the field of digital pathology, delivering precision, efficiency, and reliability to laboratories and healthcare professionals globally.
