MedAccred℠
Industry Collaboration that Drives Critical Manufacturing Process Quality throughout the Medical Device Supply Chain
MedAccred is an industry managed, consensus-driven approach to ensuring critical manufacturing process quality throughout the medical device supply chain.
Why MedAccred?
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.
Benefits
- Provides consistent/standardized critical process accreditation accepted by the Medical Device Industry resulting in fewer redundant onsite audits by multiple OEMs
- Conducts in-depth critical process audits that are compliant and consistent to accepted industry/technical standards and conducted by Subject Matter Experts
- Provides greater visibility of the supply chain to all levels and sub-tiers that provide critical processes, consistent with regulatory requirements (e.g. FDA, ISO 13485, MDD, etc.)
- Improves flow down of OEM requirements to sub-tier suppliers
- Medical device industry-accepted and consistent technical requirements leading to process discipline, greater operational efficiency and continuous improvement resulting in higher quality and lower overall cost.
An Industry Collaboration to improve Patient Safety and Product Quality
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.
Accreditation, Participation, and Events
Accreditation
The MedAccred audit and accreditation process has been designed to benefit from industry input at critical points, while minimizing customer workload where possible. Ultimately, industry representatives make all the key decisions regarding which processes require audits and which Suppliers receive MedAccred critical process accreditation.
Participation with MedAccred
Some of the biggest medical device companies in the world are MedAccred Subscribers. Still more actively participate in the program. Join the elite of the medical device industry by subscribing to MedAccred and enjoy many business and technical benefits.
MedAccred Events
We regularly present at leading medical device industry events around the world, sharing the benefits of MedAccred with key stakeholders and influencers. Panel discussions are also a frequent feature of our conference programs. See where we are going to be speaking next.
How does it work?
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.