IMI Successfully Completes ISO 13485:2016 / Medical Device Single Audit Program
IMI is pleased to announce that it has received certification for the successful completion of a Quality Management System audit under the Medical Device Single Audit Program (MDSAP). This accomplishment exemplifies IMI ability to provide safe and effective medical devices that consistently meet the highest quality and safety standards for IMI’s portfolio of Secure Drug Delivery products.
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Notified Bodies authorized by the participating Regulatory Authorities to audit under MDSAP requirements. IMI’s successful completion of MDSAP certifies compliance with the standard and regulatory requirements of multiple regulatory jurisdictions including United States FDA, Health Canada, and European International Standards.
“Hospital pharmacies and outsource compounders can feel confident that IMI’s products will provide the performance and reliability needed to support secure drug delivery into the health system,” stated Jonathan Vitello, IMI President. “We started IMI 50 years ago on American innovation with a goal to address the unique needs of pharmacy operations and provide better security of drug products within the patient care supply chain worldwide. This MDSAP achievement is further evidence that we remain on track with our goal.”