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Quality Assurance & Quality Control Solutions for Medical Devices

The quality and reliability of Medical Devices is essential to guarantee patient safety and to the growing needs of healthcare practitioners and healthcare systems.

Since 1984, Pro QC has been supporting the industry in reaching high standards of quality of medical devices with a large range of reliable and efficient quality solutions. As a globally trusted quality assurance and quality control services company, we follow the latest international medical regulations and standards to help our clients bring safer products to the market and secure their global supply chain.

Our range of quality assurance and quality control services for medical devices has been designed to answer the industry’s core needs; for example, improving factory performance, ensuring the reliability of medical manufacturers, implementing a quality management system, preparing to certification (ISO 13485, ISO 11137, ISO 15189, ISO 15378, GMP 21 QSR 820…), and controlling medical product quality.

Located in all major manufacturing countries of medical devices, our teams of inspectors and certified auditors are available for long or short-term projects. Our coverage includes the U.S., Germany, China, Mexico, the Netherlands, Ireland, France, Switzerland, Italy, UK, Canada, Poland, Belgium, Luxembourg, Malaysia, Czech Republic, Finland, and many more countries.

Our Industries & Applications

Pro QC provides quality control services for medical devices from Class I, Class II and Class III, and our experience comprises the following product categories:

Our Quality Assurance and Quality Control Services

Supplier Management

Benefit from our expertise to improve and optimize your supply chain performance.
  • Manufacturing Process Audits
  • Process Improvement
  • Production Capacity Analysis (Run & Rate)
  • Quality Investigation (root cause investigation of defective product)
  • Root Cause Analysis
  • Corrective Action Follow up
  • Process Failure Mode Effects Analysis (PFMEA)
  • APQP or PPAP Review and Approval
  • Continuous Improvement

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Supplier & Factory Audits

Our range of quality audits for the medical devices industry include:
  • Initial Supplier Evaluation
  • PPE Supplier Verification
  • ISO 13485 Quality Management System Audit for Medical Devices
  • ISO 11137 Sterilization Process Audit
  • ISO 15189 Medical laboratories, Requirements for quality and competence
  • ISO 15378 Primary packaging materials for medicinal products
  • GMP 21 QSR 820 audits for Medical Device
  • ISO 9001 Quality System Audits
  • ISO 14001 Environmental Management System Audits
  • Corporate Social Responsibility Audits
  • Combined Audits

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Product Inspections

As a third party quality control company, we offer a range of effective quality inspections for medical products such as:
  • First-article inspections to verify that the quality of your medical devices meets your requirements at an early stage of the production.
  • In-process inspection to ensure that the processes and techniques used for manufacturing are properly followed and that the quality corresponds to the specifications.
  • Pre-shipment inspections to control the quality of your order before shipping.
  • Sorting and rework: we intervene at your supplier’s factory or at your own premises to sort/rework your medical products.

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Laboratory Testing

Pro QC provides mechanical testing for medical products, furniture and accessories like wheel chair, examination chair, medical scales, cabinets, sickbed, and many more, at our labs located in Mexico, China and the USA. We also have formed alliances with accredited laboratories all around the world to meet all your testing needs. Our capabilities include salt spray chamber, hardness tester, CMM, profile projector, etc.

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Why Pro QC International?

Partnership

Pro QC genuinely sees your company and your suppliers as partners looking for growth and improvement. We don’t just give pass/fail results. We provide professional recommendations, facilitation and performance management to achieve the desired results.

Quality Dashboard

Pro QC’s Quality Dashboard provides a holistic dashboard view of your supplier portfolio including data analytics to better understand and determine the next action required at your supplier.

Experience & Expertise

Pro QC has overseen successful supplier transformation projects which has helped companies from the medical devices industry to achieve their quality goals.

Global Presence

Pro QC has agile teams of medical engineers in more than 88 countries ready to meet your quality assurance needs whether it’s a quality inspection or a comprehensive medical audit.

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    Stability

    Pro QC has been providing quality assurance, engineering and consulting services since 1984.

    Global Presence

    We offer quality solutions in over 88 countries and we are continuously expanding our network.

    Timely Feedback

    We offer online reporting and detailed reports within 24 hours of job completion.

    Quality Experts

    Our global engineering team has the requisite industry expertise to verify quality and conformance.

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    Pro QC

    Contact Your Local Office

    North America

    +1 813 252 4770

    Latin America

    +52 81 2721 0928

    India & South Asia

    +91 120 4291971

    Europe, Middle East & Africa

    +33 9 7303 6784

    Asia & Asia Pacific

    +886 2 2832 2990

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