Manufacturing for Life-Sustaining Medical Devices
Quality Assurance for Absolute Reliability
Mack develops and manufactures complex circuit boards and full-system assemblies used in Class I, II, and III medical devices. With a team of medically focused quality and regulatory experts, and a robust, mature quality management system, we consistently uphold the quality and regulatory standards imposed by life-sustaining medical devices. Our assembly processes are ISO13485- and QSR-compliant, and our quality engineers carry our rigorous quality expectations deep into our supply chain.
A Stable Manufacturing Partner for the Medical Devices Industry
Mack—founded in 1920 and debt-free—is financially strong enough to invest in the resources that support medical device manufacturing’s long product development cycles.
We provide a capable, low-risk contract manufacturing option for medical device companies seeking a long-term supplier through:
- First-rate infrastructure
- Medical staffing expertise
- Financial strength
- Mature quality processes
Medical Devices: Industry Qualifications
- Industry expert program teams
- Circuit board, electro-mechanical, and full product assembly
- Stringent quality focus
- Full product test and validation
- Integrated production quality data capture
- Centralized quality management system (QMS)
- Complete product life cycle management
- ISO9001
- ISO13485
- FDA Registered
- IPC-A-610 Class III quality standards
- FDA Quality System Regulations (QSR) 21 CFR part 820 compliant (Class II & Class III)
- 510K / PMA manufacturing
- Component and date code traceability (to reference designator)
- Obsolescence material management
- MES workflow traceability with operator traceability
- Advanced Product Quality Planning (APQP)
- Production Part Approval Process (PPAP)
- Process Failure Mode and Effects Analysis (PFMEA)
- Supplier Quality Engineering
- Formal Approved Supplier Management
- UL / CSA / TUV / CCC audit support