We are pleased to announce that Vitalograph has received the Medical Device Single Audit Program (MDSAP) Certificate. MDSAP certification is official recognition of our extremely high standards in manufacturing and supplying innovative respiratory medical devices. This significant achievement is the result of a series of rigorous audits in our Ennis facility earlier this year and the support of our hardworking, dedicated staff.
Frank Keane, CEO, comments “Vitalograph (Ireland) Ltd is delighted to have achieved MDSAP certification at our first attempt. This thorough assessment of our quality management system provides a high level of trust for our customers, one that benefits patient health and patient access, with ease of entry to multiple markets.”
MDSAP is a global certification system that allows the conduct of a single regulatory audit which centres on adherence to the QMS Standard for Medical Devices ISO 13485: 2016, along with additional requirements from five participating countries: The United States of America, Australia, Brazil, Canada and Japan.