MedAccred is an industry managed, consensus-driven approach to ensuring critical manufacturing process quality throughout the medical device supply chain.
In today’s world of global manufacturing, the supply chain is multi-tiered and geographically remote, making oversight challenging and costly. To prevent output deficiencies, critical processes and products must be validated during manufacturing to prove that they are fit for purpose, satisfy regulatory requirements and reduce overall risk.
The companies participating in MedAccred talk about the program and the role it plays in their efforts to produce high quality medical device products that enhance patient safety.
Audits are conducted on behalf of its subscribing OEM members using collaboratively created audit criteria. The accreditation is granted and accepted by the program’s subscribing OEM members. The audit criteria incorporates industry accepted performance standards and manufacturer specifications that meet the requirements of the regulator.
Process-focused Product Audits are conducted by industry approved and trained SME auditors, who have extensive experience and knowledge of their process.
Medical device industry suppliers which earn MedAccred Accreditation are added to the Qualified Manufacturers List (QML) maintained by PRI. Subscribing medical device manufacturers have access to the QML and can search for suppliers to include on their own preferred suppliers list.
Email: MedAccred@p-r-i.org
Telephone:
Americas: +1 (0) 724 772 1616
Asia: +86 (0) 10 6463 6008
Europe: +44 (0) 870 350 5011
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