Quality and Regulatory

SMC’s global quality teams operate within a robust Quality Management System (QMS). Through upfront quality planning and engagement, we execute to customers’ critical-to-quality requirements. We deploy the necessary activities and tools to ensure the appropriate levels of verification, validation, and monitoring controls are achieved.

At SMC, we provide regulated companies the assurance of electronically controlling and meeting applicable FDA and International compliance requirements.

Quality and Regulatory


Regulatory Compliance

Strategic quality deployment and early involvement results in well executed deliverables:

  • Quality Planning
  • Risk Management
  • Process Validations (IQ/OQ/PQ)
  • Supplier Quality Management

Metrology services are provided by trained and experienced staff using calibrated equipment traceable to NIST standards:

  • Programmable Contact/Non-Contact Measurements
  • Computer Tomography Analysis
  • Metrology Analysis and Reports
        • Capability Studies
        • Gage R&R
        • FAI’s

With a robust ISO-13485 certified quality management system, we provide customer assurance through: 

  • FDA Registrations
  • Customer Audit Support
  • CAPA and Complaint Handling
  • Traceability and Document Controls

All SMC manufacturing sites are FDA registered and ISO 13485 certified. Some sites are Part 4 compliant, or Bio Level 2 certified.