The purpose of the proposed project medmmap phase III (medical manufacturer medaccred accreditation pathway) is to expand the relatively narrow scope of the previous medmmap phase II project and…

The National Institute of Standards and Technology (NIST) awarded a $1,600,000 Cooperative Agreement under the Manufacturing Extension Partnership (CFDA 11.611) program to the A.I. Philpott Manufacturing Extension Partnership, doing business as Genedge Alliance. The purpose of this 2-year award, effective September 1, 2023, is to expand the Medical Manufacturer MedAccred Accreditation Pathway (MedMMap) program to increase the resilience of the U.S. medical device supply chain. Key activities include providing on-site problem resolution support, readiness assessments, and certification assistance to help small and mid-sized U.S. manufacturers achieve ISO 13485 and MedAccred accreditation. Expected outcomes include reduced product defects, FDA recalls, and industry risks, as well as increased competitiveness and resiliency across the medical device supply chain. The award does not include any sub-award activities.

Activities

SMM on-site problem resolution partner with OEM and FDA to assist in surveillance, audit, and problem resolution with critical small or mid-sized suppliers.SMM readiness assessments provide tools for SMM to self-assess the business cases and operational readiness for ISO 13485 and medaccred accreditation.ISO 13485 certification support ISO 13485 pre-audit assessments and GAP closure planning to diversify supply base, improve quality, and reduce risk in manufacturing processes. This activity would include addressing non-conformances identified in existing QMS to ensure SMM maintain accreditation. Medaccred accreditation support (focus of medmmap phase i and II) perform medaccred pre-audit assessments and GAP closure planning leveraging MEP subject matter experts. PRI will train additional subject matter experts in critical processes. Learning management resources identify, develop, and deliver training and educational resources for internal auditing and quality management.

Expected outcomes

Reduce material defects and FDA class i recalls. Reduce industry risks and the cost of poor quality in medical devices. Increased implementation and mandating of medaccred accreditation by leading oems. Increase ISO 13485 accreditations among SMM. Increase number of U.S. Suppliers supporting the medical device industry across critical processes identified by oems including plastics, PCB assembly, heat treating, and cable and wire harness assembly. Increase SMM sales and job growth in medical device supply chain enabling long-term resiliency.

Intended beneficiaries

All patients that use medical devices that integrate parts or materials manufactured by U.S. Suppliers. Medical device manufacturers (OEM and tier 1) reduce disruptions, product costs, and quality risks to increase industry competitiveness and resiliency. Small and mid-sized contract manufacturers (SMM) increase sales and job growth in medical device supply chain. Food & drug administration (FDA) reduced class i recalls and need for expanding audit capacity.

Subrecipient activities

The recipient does not intend to subaward funds.