Pre-Shipment Inspection During Production Pre-Production Inspection Factory Audit Lab Testing Supplier Verification Container Loading Social Compliance Production Monitoring Defect Sorting Sample Testing First Article Inspection

Electronics Textiles & Garments Furniture & Home Toys & Children's Automotive Medical Devices Food & Agriculture Building Materials Cosmetics Promotional Sports & Outdoors Bags, Luggage & Cases Home & Kitchen Lighting Hardware & Tools

Locations

About Us Our Story How We Inspect Who Pays Us Our Guarantee When We're the Wrong Choice Our Team Certifications Case Studies Careers

Pricing

Measuring & Dimensional Weighing Visual & Surface Color & Print Softlines Electrical Toy & Children's Safety Materials & Hardlines Climate, Food & Cold Chain Packaging, Barcode & Sampling All Kits

Blog AQL Calculator Sample Reports QC Checklists Glossary FAQ Service Finder Business Case Tool Amazon FBA Inspection First-Time Importers First Order From China Shipping Deadlines PPWR Packaging Check Quality Fade Passed But Defective Dispute Evidence

Contact

IndustriesMedical Devices

Medical Device Inspection in China

Medical devices are judged as much on paperwork as on parts — a missing UDI, a crushed pouch, or lot codes that don't reconcile can hold a shipment at customs or force a rework. Our inspectors across the Shanghai, Suzhou and Shenzhen medical clusters carry out visual, dimensional, packaging, labeling and documentation checks against the specification you approved. We are an inspection company, not a certification body: we report what we observed and measured, and we refer conformity assessment to accredited and notified bodies.

Get a quote See a sample report

We were inspecting a run of single-use infusion sets. The units looked clean — sealed, cleanly molded, correctly assembled. But the lot codes printed on the pouches didn't reconcile with the batch records the factory handed us for that run. We didn't try to decide whether the product was safe; that isn't our call to make. We photographed every code, wrote the discrepancy into the report as a critical finding, and the buyer held the shipment while their regulatory lead and the manufacturer worked it out. Two lots had been co-mingled. Every medical lot we inspect now gets the same reconciliation — unit, pouch, carton and the records supplied for the run have to agree, and when they don't, it goes in the report.

James Liu

Founder & CEO

Scope

What We Do — And What We Don't

Medical devices are the category where being precise about scope matters most. Here is exactly where our work starts and where it stops.

What a TruMark medical inspection covers

Visual inspection of every sampled unit, including product-contact surfaces
Dimensional verification against your drawing, with calibrated hand instruments
Packaging condition — pouches, trays, cartons and visibly defective or damaged seals
Labeling, IFU and UDI checks against the artwork and specification you approved
Workmanship, assembly and comparison to the approved sample
Carton counts, shipping marks and packing-list verification
Documentation checks — the records and certificates your specification calls for are present, legible and reconcile to the lot
Quantity count and AQL sampling per ISO 2859-1 (ANSI/ASQ Z1.4)

What we do not do — and will not claim to

Regulatory conformity assessment against EU MDR, FDA or any other regime
Notified-body, certification-body or registration work of any kind
Sterile-barrier validation or seal-strength, peel and burst testing (ISO 11607)
Biocompatibility, chemical, microbiological or sterility testing
Electrical-safety or performance testing to IEC 60601 or GB 9706
Software, firmware or calibration validation
ISO 13485 certification audits
Anything that constitutes, or could be presented as, a regulatory approval

Our report is an inspection record, not a certificate and not a clearance. Where testing or assessment is required, we refer it to an accredited laboratory or notified body — or coordinate it for you — and pass their result to you unchanged. TruMark is not ISO/IEC 17020 accredited; we work to ISO/IEC 17020 methodology.

What We Inspect

Products We Cover

Disposable syringes & needlesIV & infusion setsSurgical & examination glovesFace masks & respiratorsWound dressings & bandagesCatheters & cannulasSurgical instrumentsOrthopedic supports & bracesWheelchairs & mobility aidsHospital beds & furnitureDigital thermometersBlood-pressure monitorsPulse oximetersNebulizers & CPAP devicesDental consumablesIVD & diagnostic test kits

Most Common Defects We Find

Medical devices rarely fail on appearance. What we raise most often sits in the documentation, the packaging and the labeling — the things an importer can still fix while the goods are in the factory. These are the findings that recur:

Defect type

Description

Documentation & traceability gaps

Lot and batch codes on units, pouches and cartons that don't reconcile with the records supplied for the run; certificates named in your specification missing from the shipment file

Labeling, IFU & UDI errors

Missing or unscannable UDI barcode, wrong or absent IFU, ISO 15223-1 symbols missing from the label, wrong language or markings for the destination market

Packaging damage & visibly defective seals

Pouches punctured, crushed or open in the carton; seals with visible channels, wrinkles or incomplete bonding. We record what is visible — we do not test or validate the sterile barrier

Dimensional out-of-spec

Measurements outside the tolerances on your drawing, taken on the sampled units with calibrated hand instruments

Assembly & workmanship

Loose or misaligned assembly, visible contamination on product-contact surfaces, components or accessories that don't match the approved sample

Carton, quantity & shipping marks

Short or over-shipped quantities, master-carton counts that don't match the packing list, missing or incorrect shipping marks and handling symbols

Print & cosmetic defects

Flash, burrs, molding marks, smeared or illegible printing — visible breaches of the approved sample that don't affect use

Our Protocol

Inspection Checklist

Every checkpoint run, findings photographed.

Dimensional verification against your drawing with calibrated hand instruments

Visual inspection of every sampled unit under magnification, including product-contact surfaces

Visual condition check of sterile packaging — punctures, crushing, open or visibly channeled seals

Lot and batch code reconciliation — unit, pouch, carton and the records supplied for the run

UDI barcode scan for format, data content and legibility

Label and IFU check against your approved artwork, ISO 15223-1 symbols and destination-market language

Assembly, workmanship and comparison against the approved sample

Accessory, insert and consumable completeness against the bill of materials

Master-carton, inner-carton and shipping-mark verification against the packing list

Quantity count and AQL sampling per ISO 2859-1 (ANSI/ASQ Z1.4)

Document file check — the records your specification requires are present, legible and match the lot

Photographic record of the sealed cartons before opening and of every finding raised

Quality Standards

Recommended AQL Levels

Critical

Zero tolerance

Safety & function failures

Major

1.0

Significant defects

Affects product usability

Minor

2.5

Cosmetic issues

Visible but non-critical

Sample sizes are drawn per ISO 2859-1 (ANSI/ASQ Z1.4) against the AQL you set; we will tighten the critical limit below the standard tables on request. Sampling is non-destructive — sterile pouches are not opened.

Certifications

Certifications & Standards

United States

FDA UDI

We scan the barcode for format, content and legibility

21 CFR Part 820

The manufacturer's system — assessed by FDA, not by us

European Union

EU MDR 2017/745

CE marking — assessed by your notified body, not by us

ISO 13485

Manufacturer's QMS — certified by an accredited body

ISO 15223-1

Label symbols — we check they are present and correct

Global

ISO 2859-1

The sampling plan we draw your inspection sample from

ISO 11607

Sterile-barrier validation — the manufacturer's, not ours

IEC 60601-1

Electrical safety — referred to an accredited laboratory

GB 9706

China electrical safety — referred to an accredited laboratory

Coverage

Where We Inspect

Shanghai

Diagnostics, monitors & finished devices

Suzhou

Disposables & in-vitro diagnostics (IVD)

Shenzhen

Electronic medical devices & patient monitors

Changzhou

Orthopedic devices & implants

Ningbo

Molded disposables & consumables

Nanjing

Surgical instruments & sets

FAQ

Frequently Asked Questions

No, and we will never imply otherwise. TruMark is an inspection company — not a notified body, not a certification body, not a test laboratory. We are not ISO/IEC 17020 accredited; we work to ISO/IEC 17020 methodology. Our report records what our inspector saw, measured, counted and photographed against the specification you approved. It is not a conformity assessment, a CE mark, an FDA clearance or any other form of regulatory approval, and it should never be presented to a regulator or a customer as one.