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.