Medical Devices

Quality Assurance for Absolute Reliability

Mack's robust and mature quality management system was specifically designed to achieve the highest possible quality standards for repeatable manufacturing processes.  Our team of medical quality and regulatory experts develop and manufacture complex circuit boards and full system assemblies used in Class I, Class II, and Class III medical devices.  Our ISO13485:2003 and QSR compliant processes extend beyond assembly operations as our supplier quality engineering departments extend our stringent quality expectations deep into our supply chain.

Mack was founded in 1920 and maintains no debt.  This financial strength allows us to invest in the resources needed for the long product development cycles typical of medical device manufacturing.  Mack's unique combination of infrastructure, talented medical staffing expertise, financial strength, and mature quality processes provides a low risk contract manufacturing option for medical device companies searching for a highly capable and long-term supplier partner.  
 
 Medical Expertise

  • 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


Certifications and Capabilities

  • ISO9001:2008 certified
  • ISO13485:2003 certified
  • 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

Please contact us to learn more about Mack's medical device manufacturing expertise.