We help to increase the competitiveness of American medical device and medical instrument manufacturing supply chains in the global market.
Medical Manufacturers MedAccred® Accreditation Pathway SM
MedMMAP provides manufacturers and suppliers with effective audit preparation for MedAccred accreditation, to increase competitiveness, decrease industry costs, and improve patient safety. MedMMAP is an MEP National Network program, in collaboration with the Performance Review Institute (PRI), who administrates the MedAccred® program.
What is MedAccred®?
An industry managed supply chain accreditation program that reduces risk to patient safety, assures quality products and compliance with requirements as they apply to critical processes used in the production of medical devices.
What is a Critical Process?
Critical processes are those processes where the parameters are directly influenced by component geometry and/or the results cannot be confirmed by inspection. Examples include sterilization, heat treating, welding and electronic circuits.
What is a Critical Process Compliance Audit?
- Critical process audits are conducted using collaboratively created, Industry-managed performance standards and manufacturer specifications which lead to an accreditation granted by the Industry
- In-process job audits are conducted by Industry approved and trained auditors, who have extensive experience and knowledge of their process specialty
- Verification of compliance to an appropriate general quality system (such as ISO 9001 or ISO 13485) is a pre-requisite for current PRI programs
Key Supplier Benefits from Accreditation
- Provide consistent/standardized process audits accepted by the Medical Device Industry resulting in fewer redundant onsite audits by multiple OEMs
- Enhances the Supplier’s compliance status
- 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 costs
- Helps Suppliers develop a structured approach to critical process and product manufacturing
- Can use accreditation to increase client base and opportunities across the Medical Device Industry
- Opportunity to participate in the development of audit criteria and the accreditation program
How does MedMMAP fit into MedAccred Accreditation?
Many suppliers, particularly small and medium sized organizations, do not have the organizational bandwidth to efficiently and effectively prepare for a MedAccred audit. That is where MedMMAP comes in.
MedMMAP’s industry experts perform a “current state” assessment — a “pre-audit” against the MedAccred® audit critria — at the supplier’s facility, and provide an action plan to address areas which need changed before the PRI MedAccred accreditation audit.. The MedMMAP expert mentors the facility team throughout the gap closure process and can tap into the MEP National Network to assist or supplement the client team.