Medical Manufacturers MedAccred Acceditation Pathway

What Medical Manufacturers MedAccred Acceditation Pathway does

Medical Manufacturers MedAccred Accreditation Pathway (MedMMAP) is a federally funded program that prepares U.S. manufacturers for MedAccred certification, the process accreditation described as the "gold standard" among medical device purchasing organizations. Established via a NIST grant to GENEDGE Alliance, Virginia's Manufacturing Extension Partnership (MEP) Center, the program is administered through the NIST MEP National Network and delivered across 51 MEP Centers located in all 50 states and Puerto Rico, with eight partner centers of excellence providing specialized expertise in critical processes such as plastic injection molding, plastic extrusion, heat treating, sterilization, and electronics assembly.

MedMMAP's core offering is a Critical Process Assessment—a pre-audit conducted against MedAccred audit criteria that includes review of procedures, work instructions, training records, documentation evidencing competency, and on-the-floor job audits—followed by Gap Closure Plan Development and audit preparation training/mentorship to close non-conformances. A three-part "Growing with MedAccred & MedMMAP" webinar series supplements direct engagement. MedAccred is governed by a subscriber coalition of major OEMs including Medtronic, Stryker, Johnson & Johnson, Baxter, Philips, BD, Bausch Health, Boston Scientific, Roche Diagnostics, and Edwards Lifesciences, which set audit criteria and increasingly require MedAccred of process vendors; the accreditor is the Performance Review Institute (PRI), with which MedMMAP has a co-development partnership.

The business model is non-commercial: pre-audit assessments and gap closure assistance are provided at no cost to eligible manufacturers, subsidized by federal grant funding, while the actual MedAccred audit (paid to PRI) carries a $5–10K fixed fee depending on process type. Target end users are small and medium-sized U.S. manufacturers with relevant NAICS codes—both existing medical device suppliers seeking certification and aerospace, automotive, and industrial manufacturers pursuing revenue diversification into medical devices. Reported outcomes include an 89% supplier-reported value-add from certification and individual case examples such as Intertech Plastics projecting 30% medical business growth post-certification.

Name

Medical Manufacturers MedAccred Acceditation Pathway

Legal name

Medical Manufacturers MedAccred Accreditation Pathway

Website

https://medmmap.org

Company type

Private

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

MedMMAP is a federally funded NIST MEP program that provides U.S. manufacturers with free pre-audit assessments and gap closure assistance to earn MedAccred certification for medical device critical processes, serving small and medium-sized suppliers and OEMs via 51 MEP centers across all 50 states and Puerto Rico.

Ownership category

akta.pro rank

Headquarters

HQ city

Richmond

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Others

Revenue model

1. Federally Funded Program Services: MedMMAP is a federal grant program administered by NIST MEP National Network. Services are provided at no cost to eligible manufacturers, with costs subsidized through federal funding. Manufacturers only pay for the actual MedAccred audit conducted by PRI ($5-10K fixed fee depending on process).

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

MedMMAP is a federally funded program that provides U.S. manufacturers with free pre-audit assessments (Critical Process Assessments) and gap closure assistance to prepare for MedAccred Accreditation, the critical-process certification required by medical device OEMs. The program combines documentation review, on-floor job audits, corrective action planning, and training/mentorship to help suppliers become audit-ready across processes such as plastics injection molding, extrusion, electronics assembly, sterilization, and heat treating.

Product overview

MedMMAP is a single, federally funded program that provides U.S. manufacturers with comprehensive support for MedAccred certification preparation. The core offering consists of a Critical Process Assessment (pre-audit) that evaluates suppliers against MedAccred audit criteria, followed by gap closure plan development and training mentorship. MedMMAP is administered by GENEDGE Alliance through the NIST MEP National Network, with activities supported by 8 MEP Centers across the United States.

Differentiator

Problem solved

Functional benefit

Products and services

• MedMMAP Program (Medical Manufacturers MedAccred Accreditation Pathway) A federally funded program administered by the NIST MEP National Network and managed through GENEDGE Alliance that delivers efficient and effective audit preparation for MedAccred Accreditation to U.S. manufacturers, helping suppliers increase competitiveness, grow sales, decrease industry costs, and improve patient safety.
• Critical Process Assessment (Pre-Audit) A free assessment conducted to the MedAccred audit criteria that includes review of procedures, work instructions, training records, and documentation evidencing competency, along with observation of critical processing through job audits on the shop floor. Designed for U.S. manufacturers preparing for MedAccred Accreditation in critical processes such as plastics injection molding, extrusion, electronics assembly, sterilization, and heat treating.
• Gap Closure Plan Development MedMMAP works with suppliers to develop and execute a structured plan that closes all non-conformances and root-cause corrective actions identified during the pre-audit assessment, bringing suppliers to audit readiness.
• Audit Preparation Training and Mentorship Training and mentoring of supplier teams in gap closure and MedAccred audit preparation, including hands-on assistance with closing PRI MedAccred audit findings through the MEP National Network's critical process experts.

Quantifiable outcome

• 89% of suppliers report MedAccred certification added value to their business
• +3 more outcomes

Named customers16 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

19 partnerships are on record, tiered core, major and minor.

• GENEDGE AlliancecoreStrategic or Co-development PartnerGENEDGE (Virginia's MEP Center) received the NIST grant to establish MedMMAP and serves as the national program manager. They lead the program with 8 partner MEP Centers providing support across the country.
• Performance Review Institute (PRI)coreStrategic or Co-development PartnerPRI is the accreditor for MedAccred and has partnered with the MEP National Network to develop critical process experts who can assist manufacturers in preparing for MedAccred Accreditation. PRI manages the audit criteria and accreditation process.
• NIST MEP National NetworkcoreStrategic or Co-development PartnerFederal grant program administered by NIST MEP National Network providing the funding and infrastructure for MedMMAP. Comprises 51 MEP Centers with over 1,300 experts across all 50 states and Puerto Rico.
• MedtroniccoreStrategic or Co-development PartnerLeading MedAccred subscriber and OEM driving MedAccred certification requirements. Part of the group of subscribers that manages the program, determines audit criteria, and selects auditors.
• StrykercoreStrategic or Co-development PartnerLeading medical device OEM requiring MedAccred from process vendors. Stryker is tying process vendors to MedAccred requirements and FDA is taking notice of this practice.
• Johnson & JohnsoncoreStrategic or Co-development PartnerMedAccred subscriber driving certification requirements. Part of the subscriber group managing the program and determining audit criteria.
• BaxtercoreStrategic or Co-development PartnerMedAccred subscriber and medical device OEM driving certification requirements.
• PhilipscoreStrategic or Co-development PartnerMedAccred subscriber and medical device OEM driving certification requirements.
• BDcoreStrategic or Co-development PartnerMedAccred subscriber and medical device OEM driving certification requirements.
• Bausch HealthcoreStrategic or Co-development PartnerMedAccred subscriber and medical device OEM driving certification requirements.
• Boston ScientificcoreStrategic or Co-development PartnerMedAccred subscriber and medical device OEM driving certification requirements.
• Roche DiagnosticscoreStrategic or Co-development PartnerMedAccred subscriber and medical device OEM driving certification requirements.
• Edwards LifesciencescoreStrategic or Co-development PartnerMedAccred subscriber and medical device OEM driving certification requirements. Representative spoke at webinars about why MedAccred is important in sourcing decisions.
• Edwards LifesciencescoreStrategic or Co-development PartnerDannette Crooms from Edwards Lifesciences spoke at Growing with MedAccred & MedMMAP webinar explaining why MedAccred is an increasingly important factor in their sourcing decisions.
• 8 Partner MEP CentersmajorChannel Partner/ Reseller/ DistributorMedMMAP national activities are supported by 8 centers of excellence. These centers have developed critical process expertise in areas such as plastic injection molding, plastic extrusion, heat treating, and other critical processes.
• New Jersey MEPmajorChannel Partner/ Reseller/ DistributorOne of the veterans of the MedMMAP program with medical device OEMs such as Johnson & Johnson nearby. Focus on plastics sector and has worked with several suppliers on MedAccred certification.
• Michigan Manufacturing Technology CentermajorChannel Partner/ Reseller/ DistributorMichigan's MEP Center experienced in supporting businesses pursuing MedAccred certification with critical process expertise in plastic injection molding and plastic extrusion.
• MedmarcminorGTM or Marketing PartnerLeading provider of insurance solutions in the medical device sector, supporter of MedMMAP program and MedAccred certification. Provides video content about the program.
• NadcapminorStrategic or Co-development PartnerMedAccred was modeled by the medical device industry after the Nadcap certification used in aerospace and defense sector. Nadcap provides a reference model for MedAccred's critical process certification approach.

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• BSI Group: BSI is a major global certification body issuing ISO 13485 and other quality management certifications to medical device manufacturers — competing for the same supplier-certification wallet that MedMMAP indirectly supports (via MedAccred/ISO 13485 prerequisites).
• SGS: SGS is a global testing, inspection, and certification company that audits and certifies medical device manufacturers to ISO 13485 and related standards. Adjacent peer in the supplier-quality/certification services market MedMMAP serves.
• TÜV Rheinland: TÜV Rheinland provides medical device testing, ISO 13485 certification, and quality systems audits globally. Comparable to MedMMAP as part of the broader supplier certification and audit prep ecosystem serving medical device manufacturers.
• Intertek: Intertek provides quality assurance, testing, and certification services for medical device manufacturers (ISO 13485, CE marking, process audits). Comparable to MedMMAP as a certification-adjacent service provider supporting supplier compliance for medical OEMs.
• NSF International: NSF International provides ISO 13485 certification, quality systems auditing, and medical device testing services. Comparable to MedMMAP as part of the supplier certification and audit ecosystem serving medical device OEMs and contract manufacturers.
• UL Solutions: UL Solutions offers testing, certification, and quality assurance services for medical devices and related industries. Comparable to MedMMAP as an established certification/testing provider supporting medical device manufacturers' quality and compliance programs.
• TÜV SÜD: TÜV SÜD is one of the largest notified bodies and certification providers for medical devices (ISO 13485, MDR/MDSAP audits). It operates in the same regulatory-quality services space that MedMMAP helps suppliers navigate for MedAccred certification.
• DEKRA: DEKRA is a major global certification and testing body offering ISO 13485 and process audits to medical device suppliers — overlapping with the audit-preparation/certification quality services domain that MedMMAP addresses through its MedAccred pathway.

Emerging players

• NAMSA: NAMSA provides medical device testing, regulatory, and quality consulting services — comparable to MedMMAP as a specialized service provider helping medical device manufacturers and their supply chain achieve compliance with quality and regulatory standards.

Direct peers

• Performance Review Institute (PRI): PRI operates the MedAccred accreditation program that MedMMAP helps manufacturers prepare for. It is the closest functional peer — both organizations are central to the MedAccred ecosystem, with PRI conducting the actual audits and MedMMAP providing the federally-funded preparation pathway.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/medmmapm
• LinkedInlinkedin.com/company/medical-manufacturers-medaccred-accreditation-pathway

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Medical Manufacturers MedAccred Acceditation Pathway