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Medical Device Manufacturing Quality and Regulatory Compliance

As an ISO 13485:2016-compliant manufacturer, Primo Medical Group has a long-established reputation, with over 70 years of experience manufacturing products for various, stringently regulated industries. Our expertise is built upon our persistence to consistently meet or exceed the quality requirements of regulatory entities and the expectations of our clients. By maintaining continuous control over all aspects of our processes, we provide well-documented quality control and regulatory compliance to ensure the safety, performance, and caliber of our solutions.

Why Quality and Regulatory Compliance Matter in Medical Device Manufacturing

To ensure devices are consistently designed and manufactured as intended, a strong quality system and regulatory compliance reduce defects, contamination, software errors, and other failures that can affect safety and performance. With several processes in place, Primo Medical Group provides solutions to address medical device quality and compliance. From proper documentation to meeting FDA requirements and mitigating regulatory risk, we offer a robust system, backed by ISO 13485 manufacturing capabilities and our status as an FDA-registered contract manufacturing partner.

Medical Device Quality Control Services and Inspection Capabilities

To ensure robust quality control for products in highly regulated industries, we offer a range of services for quality control and inspection, including:

  • Customer Specific Quality Inspection Plans
    • Customized Sampling Plans
    • ANSI/ASQ z.1.4 and Military Standards and Specifications
    • Geometric Tolerancing
  • Supplier Management
  • Statistical Process Controls
  • Equipment Installation Qualification and Preventative Maintenance
  • Corrective and Preventative Action Program
  • Complaint Management
  • State of the Art Inspection Equipment
    • Keyence Digital Imaging Systems
    • Programmable CMMs
    • CAD-Based Inspection
  • Exceptional Level of Training

Validation and Medical Device Regulatory Compliance Services

Our capabilities additionally include various regulatory compliance and validation services, guaranteeing products meet the stringent standards required by governing regulations, such as:

  • Process Validations
    • Capability Analyses
    • Special Validations: Sterilization, Packaging
  • Gage R&R Studies
  • Component Qualifications
    • First Article Inspection
    • Operational Qualification
    • Performance Qualification
  • Test Method Development and Validation
  • Software Validation
  • Compliance and Remediation Testing
  • Gap Analyses
  • Risk Management File Development

Quality Systems and Regulatory Support from Primo Medical Group

  • ISO 13485 Manufacturing: Compliant with ISO 13485:2016, Primo Medical Group is committed to delivering the highest standards of medical device quality, safety, and traceability, ensuring our products align with global requirements.
  • FDA Quality Systems Compliance: Our services are compliant with FDA Quality Systems Regulations, and we are an FDA-registered contract manufacturer for medical devices.
  • Continuous Improvement and Lean Manufacturing: We embrace industry-recognized process improvement tools, including continuous flow, mistake proofing, structured problem solving, 5S workplace organization, and changeover reduction, to demonstrate our commitment to developing efficient processes to solve client challenges.
  • Six Sigma Process Improvement: Using a disciplined, data-driven approach and methodology for eliminating defects, Six Sigma is a measure of quality that strives for near perfection in medical device manufacturing.
  • ITAR Compliance and Registration: Primo Medical Group is registered with the Office of Defense Trade Controls Compliance as a manufacturer, ensuring compliance with International Traffic in Arms Regulations (ITAR) for aerospace, defense, and other highly regulated industries.
  • Quality and Regulatory Consulting Services: We offer a full range of consulting support services in the medical device industry, with experience in building quality systems that meet or exceed industry requirements.

Applications for Medical Device Quality Control and Regulatory Compliance Support

Our quality control management system and regulatory compliance standards serve various industries with comprehensive support to ensure the safety and performance of finished products. Primo Medical Group has partnered with start-ups and corporate innovators, assisting manufacturing operations for a wide range of applications across industries, such as:

Partner with Primo Medical Group for Compliant, Reliable Solutions

Since 1953, Primo Medical Group has built a reputation based on trust, quality, and consistency, becoming a leader in innovative solutions with over 145 patents. With a commitment to maintaining the highest standards of quality and compliance at every stage of our manufacturing processes, we are ISO 13485:2016 certified and FDA-registered to ensure each project meets exacting requirements for performance and safety across various industries. From process validation to quality control, documentation support, and risk mitigation, our team offers comprehensive experience in precision-driven solutions to meet your requirements. Contact Primo Medical Group to discuss your project or request a quote to get started.