COVID-19 - Medical Device &
PPE Supplier Verification

 

COVID-19 - Medical Device & PPE Supplier Verification & Inspection Service

Due to the COVID-19 virus, the world is desperately scrambling for Medical Personal Protective Equipment (PPE). Whether for personal, commercial or medical use, everyone is competing for a limited supply of legitimate PPE products and services. This is a desperate time for both buyers and sellers. We have already witnessed numerous cases of fake suppliers and scams resulting in huge losses on both sides, and in some cases, those losses have reached one million USD. As a comprehensive answer to this challenge, we have developed a COVID-19 Supplier Verification and Inspection service that has already helped numerous clients prevent some of the following supply chain challenges:

  • Opportunistic supplier or reseller scams
  • PPE purchases from unauthorized suppliers
  • Defective, contaminated and dysfunctional medical PPE
  • Custom clearance issues due to government restriction or invalid product certification
  • Unexpected quality costs due to quality and production issues

The graphic below shows where Pro QC can support buyers along the purchasing journey and avoid the costly challenges listed above.

Commercial losses aside, we all desire that the end recipient receives functional, protective and certified medical PPE and devices. Read more about the Supplier Verification and Inspection services below or get in touch immediately for more details on how we verify your suppliers for you.

COVID-19 – Medical Device & PPE Supplier Verification Service

Pro QC urges all buyers to remain vigilant especially when purchasing medical PPE from a new or untested supplier. Our COVID-19 Supplier Verification service will ensure that a stringent process is followed to verify any new supplier and then ensure rigorous quality controls remain in place until the goods are loaded for shipment. All our on-site evaluations and reports are prepared by our ISO 13485 certified, GMP auditors.

What is included in our Supplier Verification Report?

  1. Pro QC’s risk evaluation & recommendation
  2. Supplier profile
  3. Factory business license
  4. Factory standard certifications (i.e. ISO 9001:2015, ISO 13485:2016, GMP for Medical Devices, others…)
  5. Product certification research, checking and verification against FDA, CE and other market regulations
  6. General production environment observations
  7. PPE product catalogue, certificate, quantity in-stock, quantity per package
  8. Legal export locations & existing product certificates
  9. Current factory staffing capacity
  10. Other general issues
  11. Photo evidence and report

Off-site (Remote) Supplier Verification for urgent purchase order

In general, on-site supplier verification is recommended and requires approximately three to five days to arrange. However, we understand urgent cases arise and as a response we provide an off-site Supplier Verification Service. Although not as detailed as the on-site service, it can be more time and cost effective for our client. Pro QC has a strict photo evidence guideline for accepting remote photo evidence from suppliers which ensures the authenticity of the photo. If the case is urgent, ask about our off-site or remote Supplier Verification service.

COVID-19 – Medical Device & PPE Inspection Service

Once a supplier’s authenticity and capacity has been assured, Pro QC recommends a product inspection before the goods leave the supplier’s facility. The third-party inspection will the verify product conformance to design and quality requirements. Pro QC has experience inspecting a wide range of personal protective equipment & medical devices including:

  • PPE Masks (Single use & surgical medical mask, and pollution masks)
  • PPE Gloves (Medical gloves – latex, vinyl & other protective gloves for professional use)
  • Protective Clothing & Footwear (medical gowns, life vests & high-visibility vests)
  • Eye & Face Shields
  • COVID – 19 Test Kits
  • Other PPE for Leisure Purposes (bike helmets, diving suits and many others)

Pro QC follows the International Inspection Standard ANSI Z.1.4-2003 for sampling. Inspection plans include general quality criteria covering appearance, functionality, packaging integrity, workmanship, and other custom requirements. PPE products are also inspected against product and region-specific standards such as EN14683, ASTM F2100 & NIOSH for medical masks; ASTM D5151, EN 455 for medical gloves and EN 13795 & ASTM F2407 for medical gowns. Noteworthy quality inspection checkpoints are included in the table below.

Medical Masks Medical Gloves Medical Gowns
  • Appearance & internal check
  • Fitting check & basic function
  • Pull test on ear loop/seam
  • Odor & color migration test
  • Leak/Waterproof test
  • Screening adhesion test
  • Flammability test
  • Fitting check
  • Dimension test
  • Thickness test
  • Leak test
  • Tensile strength test
  • Puncture resistance test
  • Odor & color check
  • Measurement test
  • Fitting test
  • Flammability test
  • Fatigue test
  • Tensile strength test
  • Tear resistance test
  • Seam strength test
  • Lint generation test
  • Liquid barrier performance instrumentation (AAMI)

Medical Masks
  • Appearance & internal check
  • Fitting check & basic function
  • Pull test on ear loop/seam
  • Odor & color migration test
  • Leak/Waterproof test
  • Screening adhesion test
  • Flammability test
Medical Gloves
  • Fitting check
  • Dimension test
  • Thickness test
  • Leak test
  • Tensile strength test
  • Puncture resistance test
  • Odor & color check
Medical Gowns
  • Measurement test
  • Fitting test
  • Flammability test
  • Fatigue test
  • Tensile strength test
  • Tear resistance test
  • Seam strength test
  • Lint generation test
  • Liquid barrier performance instrumentation (AAMI)

A multifaceted approach to quality assurance of Personal Protective Equipment begins with verification of the supplier, then the inspection of the products, and is completed with container loading supervision. For more information or pricing contact us using the forms at the side or bottom of the page.


Pro QC Blog Posts & Related Offerings

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Why Choose Pro QC?

  • 35 years of experience
  • Experienced Medical Engineers
  • Follow latest standards & technologies
  • Results received within 24 hours
  • Responsiveness & flexibility
  • Global coverage in 88 countries

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