Quality Assurance & Quality Control Solutions for Medical Devices

40+ Years of Excellence Quality Assurance & Quality Control Solutions for Medical Devices Pro QC helps manufacturers ensure compliance, improve performance, and deliver safe medical products worldwide Contact Us 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, FDA Quality Management System Regulation (QMSR), 21 CFR Part 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. Contact Us Get a Quote Sample Reports 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: In vitro diagnostics Medical, surgical and dental instruments Powered / wireless / connected medical devices Medical furniture Needles/catheters and cannulae Ophthalmological products Orthopaedic devices Medical imaging machines Medical Implants Surgical Masks/Personal Protective Equipment (PPE) And many more Request a quote 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) Medical Device File Validation APQP/PPAP assistance for Medical Device Continuous Improvement Learn more Supplier & Factory Audits Our range of quality audits for the medical devices industry include: Supplier Quality Audits PPE Supplier Verification ISO 13485 Quality Management System Audit for Medical Devices MDSAP Audits ISO 11137 Sterilization Process Audits FDA Quality Management System Regulation (QMSR), 21 CFR Part 820 audits for Medical Device ISO 9001 Quality System Audits ISO 14001 Environmental Management System Audits Corporate Social Responsibility Audits Combined Audits Learn more 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 (FAI) to verify that the quality of your medical devices meets your requirements at an early stage of the production. In-Process Inspections (IPI) to ensure that the processes and techniques used for manufacturing are properly followed and that the quality corresponds to the specifications. Pre-Shipment Inspections (PSI) 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. Learn more 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 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. Learn more Request a quote Pro QC International Our Service Reports Detailed & Actionable Following International & Industry Standards 24 Hours Report Delivery for Inspections 48-72 Hours Report Delivery for Audits View sample reports Download Sample Reports ISO 13485 audit sample report ISO 11137 audit sample report ISO 17025 audit sample report ISO 15189 audit sample report ISO 15378 audit sample report FDA Quality Management System Regulation (QMSR), 21 CFR Part 820 audit sample report ISO 9001 audit sample report ISO 14001 audit sample report SA8000 audit sample report Why Pro QC International? Advanced Quality Analysis Industry-leading quality dashboard, analytics, and supplier performance analysis tools and framework Expert-Led Solutions Technical expert advice from first contact ensures reliable solutions are executed with precision Qualified Resources Resource transparency and the right qualifications safeguard your interests on every project at every supplier Globally Aligned Operations Operational processes are optimized and aligned for a seamless cross-regional experience Stringent Technical Oversight Meticulous technical preparation, guidance throughout the engagement, and report review by senior engineers Single Contact Point A single contact point for quality services globally simplifies your supply chain Stability and Expertise Founded in 1984, over 40 years of experience make Pro QC a trustworthy and dependable quality partner Pro QC Blog Posts & Related Offerings Find out more about our related services by clicking below: Pro QC Blog Five Things You Should Know About ISO 13485 Read More Pro QC Blog Manufacturing Medical Devices During COVID-19? Know This… Read More Pro QC Blog Understanding Medical Device Audits and Audit Reports Read More Click Below to Improve Product Quality with Pro QC Contact us Get a Quote or Book a Service We will be happy to give you more information about our quality solutions. Please fill in this form to contact us. We will respond as soon as possible. If you would like to submit your CV, please click here. Contact Us by Email Contact Us by Phone North America +1 206 397 1145 Mexico +52 55 9990 7885 Colombia +57 601 9190355 United Kingdom +44 330 094 5589 France +33 9 7303 6784 Germany +49 15630 810151 Australia +61 2 8252 7691 India & South Asia +91 227 189 7407 Asia & Asia Pacific +886 2 2832 2990 Stability Pro QC has been providing quality assurance, engineering and consulting services since 1984. Global Presence We offer a dedicated Account Manager and quality solutions in over 100 countries. 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.