Our ISO certifications and ITAR & FDA registration represent our commitment to excellence
Quality is not confined to one department or team at MME group. Quality is instilled at every level of the company and is the cornerstone of all that we do. We hold ourselves accountable for product outcomes; accountability defines our culture.
Quality Control
You dictate quality measurement criteria. We work with the end result in mind and complete advanced planning and risk analysis. Along with your quality controls, we apply a tiered quality system appropriately designed to your program needs. We support standard qualification to full FDA validation.
Quality Management Systems
We hold an ISO 9001:2008 certification for quality management systems; ISO 13485:2012, a specialized certification for medical component manufacturing; ITAR and FDA registration for adhering to U.S. export laws for government projects.
Our ISO 9001:2008 quality management standard ensures that we meet high quality standards set forth by MME group, as well as those of our customers.
The ISO 13485:2012 certification demonstrates our ability to manufacture medical components and related services that consistently meet customer requirements and regulatory requirements.
We are ITAR registered. ITAR registration is awarded to companies who abide by strict security and compliance regulations enforced by the U.S. Department of State. ITAR registration ensures that we operate in accordance with federal rules and regulations related to defense controls.
We are proud to announce that we are approved by the FDA to register products produced in our facilities. Our 42 years of manufacturing experience has involved many milestones, and this is our most recent. Our registration number is 3006535109, and we are compliant to 21 CFR Part 820.
UL and CE Certifications
The UL (North America) and CE (European Union) certification organizations grant the distinctive UL and CE marks on products that have been evaluated and meet rigorous standards for safe operation.
UL and CE certifications are part-specific. MME group can file paperwork and obtain the certification on your company’s behalf.
Quality
Certifications
• ISO 13485:2012
• ISO 9001: 2008
• ITAR M34528
• FDA 3006535109
Collaborative Product Qualification
• IQ, OQ, PQ Qualification and Validation
• Automotive PAPP
• Control Plan
• FMEA / PFMEA
• SPC Analysis
• Cpk / Ppk Analysis
• FAI
• Supplier Quality Management
• Incoming Inspection
• Melt Flow Index Testing
• Pull Force Testing
• Moisture Testing
• In Process Inspection
• In Process Inspection Fixtures
• Non-destructive thickness checks
• Gage R&R
• Lot Traceability