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Premium stainless steel cardiothoracic instruments

Pemco Medical

Quality Assurance

Inspection discipline that supports dependable reusable instrument performance.

🇺🇸American Made
Since 1955
Surgical
Precision
Reusable
Solutions

Quality Assurance

Inspection discipline, manufacturing consistency, and reusable performance support.

Quality at Pemco is more than a checkpoint; it is a manufacturing culture. It is a manufacturing mindset that shapes materials, machining, finishing, refurbishment, and customer support.

  • Process discipline and product consistency
  • Functional review and inspection
  • Material awareness and finish quality
  • Long-term focus on dependable reusable performance
Quality review of reusable surgical instruments

Quality Management

ISO 13485:2016 certified quality management system.

Pemco Medical’s quality management system supports the design, manufacture, and service of non-sterile surgical retraction systems, perfusion cannula, intracardiac suckers, and stabilizer arms.

  • ISO 13485:2016 certified
  • Certificate valid through June 19, 2029
  • Scope includes design, manufacture, and service
  • Supports buyer confidence for hospitals, distributors, and biomedical teams
ISO
13485

ISO 13485:2016 Certificate

Certification validates Pemco Medical’s quality management system for medical device design, manufacturing, and service scope.

View Certificate

Traceability Support

Laser-engraved identification supports quality and documentation workflows.

Permanent part markings can support product identification, lot visibility, and manufacturing accountability on appropriate stainless steel components.

  • Durable marks on polished stainless steel
  • Supports part-number and lot reference visibility
  • Integrated with Pemco Medical’s manufacturing workflow
Laser engraving setup for stainless steel part identification

Quality System Certification

ISO 13485:2016 Certified Quality Management System

Pemco Medical’s quality management system scope includes design, manufacture and service of non-sterile surgical retraction systems, perfusion cannula, intracardiac suckers and stabilizer arms.

View Certificate

Built for Surgical Performance

Let’s Work Together to Advance Patient Care.