Milford, CT—March 4, 2019—Bernoulli Health, the leader in real-time clinical surveillance, announced that it has received the International Organization for Standardization (ISO) 13485:2016 and Medical Device Single Audit Program (MDSAP) certifications following successful audits that took place at Bernoulli Health's headquarters in Milford. The audits were completed in October 2018 by Bernoulli's notified body, Intertek.
"Successful completion of the MDSAP/ISO 13485:2016 certification is a key milestone for Bernoulli Health," said Arthur Pangaio, Bernoulli's Director Quality and Regulatory Affairs. "This accomplishment re-emphasizes Bernoulli's on-going commitment to deliver safe and efficacious products to our customers."
According to the U.S. Food and Drug Administration, the MDSAP allows for one regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements.
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ISO 13485:2016 is the state-of-the-art quality management system standard for medical devices, under which an organization demonstrates its ability to provide medical devices and related services that consistently meet applicable regulatory requirements. ISO is an independent, non-governmental international organization that sets standards for compliance with industry best practices.
The MDSAP allows medical device manufacturers to be audited once for compliance to ISO 13485:2016 and regulatory requirements of up to five different regulatory jurisdictions, including Australia, Brazil, Canada, Japan, and the United States. The program's main mission is to jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.
Bernoulli is a recognized leader in medical device integration (MDI). It's flagship platform, Bernoulli One™, is the market's only real-time, end-to-end, connected healthcare platform. Bernoulli One collects, aggregates, and distributes patient-generated data, including alarms and waveforms, from a broad range of medical devices in real-time, as well as retrospective data from the enterprise electronic health record. This provides clinical teams with instant access to a holistic and medically contextual portrait of a patient's condition.