McArthur Medical Sales Inc. Receives ISO 13485:2016 & MDSAP Certification


McArthur Medical Achieves ISO 13486:2016 and MDSAP Certification

“McArthur Medical is excited to achieve this milestone, enabling us to provide Canadian manufactured innovations to clinicians, which greatly enhances therapy for the patients they serve. In addition, it provides the framework to continue to grow the MMSI-brand portfolio.”

McArthur Medical Sales Inc., a Canadian leader in medical devices for neonatal, anesthesia, and respiratory care has received both ISO 13485 medical manufacturing certification and Medical Device Single Audit Program certification (MDSAP).

McArthur Medical Sales Inc. (MMSI) celebrates its MDSAP certification for its unique respiratory products, ODAPT ™, EXHALO ™, and the international award winning Flusso adapters, Flusso By Pass ™ and Flusso TFI ™. The MDSAP certification means that products meet the requirements of current regulatory standards required for medical devices by Health Canada. Kyle McArthur, General Manager, said, “McArthur Medical is excited to achieve this milestone, enabling us to provide Canadian manufactured innovations to clinicians, which greatly enhances therapy for the patients they serve. In addition, it provides the framework to continue to grow the MMSI-brand portfolio.”

The management team at McArthur Medical made a decision to move ahead to implement a quality management system as the first step to preparing for ISO certification. “Certification to the standard requires an organization’s quality management system to pass a third-party Medical Device Single Audit Program, and we knew that becoming certified would be an important step to ensuring continued success in of our company,” said McArthur.

McArthur Medical Sales is a family-owned and operated distributor and manufacturer of medical equipment. Founded in 1984, McArthur Medical has built a reputation as an industry leader in medical device distribution boasting a team with over 225 years of clinical experience. In the last several years, it has developed a number or respiratory medical products available in several countries. “As we’ve continued to grow and advance in the industry, undergoing the process to become ISO/MDSAP certified just made sense,” added McArthur.

To learn more about McArthur Medical and its product offerings, visit http://www.mcarthurmedical.com

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