Quality and certificates — Rich Medical
Inside the production center.
Rich Medical is a professional manufacturer with more than 20 years of experience specializing in the production and export of medical products. We have a production center — a factory area of more than 20,000 m², including a 5,000 m² dust-free workshop, an 800 m² ethylene oxide sterilization room and a 200 m² microbiology laboratory — that can produce high-quality medical products.
From raw cotton to a sealed carton.
Eight stations, one site. Nothing is subcontracted, so a batch never leaves our records — and a correction is made in our building, not someone else's.
- 01
Raw material intake
Cotton, gauze, non-woven and resin checked against the approved sample; gram weight, absorbency and whiteness logged before the batch is accepted.
- 02
Slitting & converting
Rolls cut to width in the dust-free workshop, with the machine record kept against the batch number.
- 03
Forming & impregnation
Cotton rolls, gauze plies and scrub brushes formed and impregnated — dry, 4% CHG or 7.5–10% iodophor.
- 04
Kit assembly
Components counted into the tray against your content list, then sealed in the pouch printed with your artwork.
- 05
EO sterilization
On-site ethylene oxide sterilization workshop, cycles run in-house with parametric release recorded per load.
- 06
Aeration & lab release
Residue aeration, then bioburden and sterility testing in our own microbiology laboratory.
- 07
Outer packing
Cartons marked to your instruction, quantity and gross weight verified against the proforma invoice.
- 08
Warehouse & loading
Palletised in the finished-goods warehouse, photographed before the container is sealed.
Every station keeps a record. Batch numbers run from raw material to carton, so a sterility query on a shipment from two years ago can still be traced back to the load and the test result.
The marks behind every quotation.
Scanned copies are sent with every quotation. Originals are available for inspection at the plant or notarised on request.
Certified medical device quality management system covering production at the Taizhou site.
The standard the 800 m² ethylene oxide room runs to, with a record kept per sterilization cycle.
Declaration of conformity issued per product family for European distribution.
Establishment registration and device listing documentation, released to qualified buyers.
Third-party audited supplier file held on the SGS verification platform.
Sterility that never leaves the building.
In-house EO sterilization
Ethylene oxide cycles run on site with parametric release records kept per batch — no third-party sterilizer in the chain.
Microbiology laboratory
Bioburden, sterility and absorbency testing before release, with the raw data retained and available on audit.
Batch retention
Every shipment keeps a retained sample and its inspection record, so a reorder can be matched to the original specification years later.
Four checks between cotton and container.
Incoming material
Gram weight, absorbency and whiteness verified against the approved sample before the batch is accepted.
In-line
Seal strength, count and label position checked at fixed intervals through each shift.
Sterility release
Laboratory release before packing; a batch does not ship on a verbal OK.
Pre-shipment
Carton marks, quantity and shipping documents verified against the proforma invoice before the container is sealed.
What the checks look like.
Photographs from the clean room, the converting line and the packing stations — the same rooms an auditor walks through.
Cartons photographed before the container is sealed.
Packing is where most claims are born — crushed cartons, short counts, marks that do not match the destination. We photograph the load and send the images with the shipping documents.
Packing
Polybag, pouch or display carton — sized so the goods survive the last mile, not just the sea freight. Carton dimensions and gross weight go on the packing list.
Transport
Sea freight FOB or CIF from Shanghai and Ningbo, air freight for samples and urgent lines, and express for small repeat orders.
Documents
COA, MSDS, certificate of origin and packing list issued with the shipment; CE declaration of conformity where the line requires it.
What ships with every order.
Not offered on request — issued as part of the shipping documents.
- Certificate of analysis (COA) per batch
- Material safety data sheet (MSDS)
- Certificate of origin for customs
- CE declaration of conformity where applicable
- Packing list with carton dimensions and gross weight
Need the paperwork for your market?
Send the destination and product line — we will confirm in writing which certificates apply before you order.