BLOOMINGTON, Ind.--(BUSINESS WIRE)--Cook Medical is pleased to be one of the global medical device companies to collaborate internationally with regulatory authorities on the Medical Device Single Audit Program (MDSAP).
The value of developing a global program to audit and monitor medical device manufacturing for patient safety was recognized at the International Medical Device Regulators Forum inaugural meeting in 2012. That meeting led to the creation of MDSAP.
MDSAP International Coalition Organizations:
- US Food and Drug Administration (FDA)
- Health Canada
- Therapeutics Goods Administration (TGA) Australia
- Agência Nacional de Vigilância Sanitária (ANVISA) Brazil
- Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) Japan
“This progressive approach to regulatory oversight is very exciting,” said Pete Yonkman, president of Cook Medical. “We recognize that good collaboration among regulatory agencies and industry enables more efficient and flexible use of both regulatory and company resources.”
The MDSAP enables regulatory oversight of manufacturers’ quality management systems while minimizing the regulatory burden on industry. It also promotes more efficient and flexible use of regulatory resources through work sharing and mutual acceptance among regulators while respecting the sovereignty of each authority. It also leverages, where appropriate, existing conformity assessment structures.
The Cook Medical plant in Limerick, Ireland, was chosen to trial this new auditing approach. The facility, which employs over 800 staff, underwent a two-day initial certification audit in April, which was led by TÜV SÜD of Germany. It is the first Irish site to take part in MDSAP. This audit is one of six global MDSAP audits to date.
About the Medical Device Single Audit Program:
- It is based on a three-year audit cycle.
- The initial certification audit constitutes a stage-one and stage-two audit of a quality management system.
- A partial surveillance audit takes place in each of the following two years.
- A complete recertification audit is performed after three years.
About Cook Medical
Since 1963 Cook Medical has worked
closely with physicians to develop technologies that eliminate the need
for open surgery. Today we are combining medical devices, biologic
materials and cellular therapies to help the world's healthcare systems
deliver better outcomes more efficiently. We have always remained family
owned so that we have the freedom to focus on what we care about:
patients, our employees and our communities. Find out more at www.cookmedical.com, and
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