Quality Assurance & Quality Control Solutions for Medical Devices
Pro QC helps manufacturers ensure compliance, improve performance, and deliver safe medical products worldwide
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, 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.
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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)
- Medical Device File Validation
- APQP/PPAP assistance for Medical Device
- Continuous Improvement
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
- 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
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.
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.
Pro QC International
Our Service Reports
Detailed & Actionable
- Following International & Industry Standards
24 Hours
- Report Delivery forInspections
48-72 Hours
- Report Delivery for Audits
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:
Click Below to Improve Product Quality with Pro QC
Contact usGet a Quote or Book a Service
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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
+91 120 508 9113
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.