Solar Atmospheres Inc. announced that it has become the first company to receive MedAccred accreditation. Medical prime contractors are demanding that environmental conditions are controlled, processes validated and the risk of foreign object debris (FOD) reduced. The Performance Review Institute (PRI) states that MedAccred is an industry-managed supply-chain oversight program that bolsters patient safety. It does this through clarification of requirements and better identifying how they apply to critical processes used in the production of medical devices.
According to PRI, MedAccred accreditation is one of the ways in which the medical device manufacturing industry identifies those suppliers capable of providing superior critical process manufacturing to the industry.
The benefits of MedAccred include:
- Provides consistent/standardized critical process accreditation accepted by the medical device industry, resulting in fewer redundant on-site audits by multiple OEMs
- Conducts in-depth critical process audits by subject-matter experts that are compliant and consistent to accepted industry/technical standards
- 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.
