Quality Inspection and Audit Services for Medical Devices

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, 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.

Medical Devices

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

Get a Quote Sample Reports

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

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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

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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 (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.

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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.

Pro QC Blog Posts & Related Offerings

Pro QC Blog

Five Things You Should Know About ISO 13485

Pro QC Blog

Manufacturing Medical Devices During COVID-19? Know This…

Making Sure Your Personal Protective Equipment Suppliers Are Verified

Pro QC Blog

Understanding Medical Device Audits and Audit 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

GMP 21 QSR 820 audit sample report

ISO 9001 audit sample report

ISO 14001 audit sample report

SA8000 audit sample report

to request a personalized report template for your project

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.
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Medical Devices

Quality Assurance & Quality Control Solutions for Medical Devices

Our Industries & Applications