How we work
Quality System and Export Documentation
A supplier file your procurement team can close, and a plain answer about what the certificates do and do not cover.
Orthopaedic soft goods are medical devices, and the buyer usually carries the regulatory responsibility in their own market. That makes the honest question not whether a factory claims approval, but what documentation it can actually put in your supplier file. Da Gao holds ISO 9001:2015 and ISO 13485:2016. It does not hold, and will not claim, market registration on your behalf.
Stage by Stage
Where Each Step Usually Breaks and What Happens Here Instead
Supplier Qualification
Problem. A supplier questionnaire returned with blanks stalls the whole onboarding.
How it works here. ISO 9001:2015 and ISO 13485:2016 certification, a 7,000 m² site operating since 1995, and 80 staff including 11 technical staff, are all documented facts we can answer with.
Scope Clarification
Problem. Buyers are told a certificate means more than it does, and find out during a market audit.
How it works here. We state plainly that ISO 13485 covers the manufacturer's quality management system. It is not a CE mark, an FDA clearance or a market registration.
Product Documentation
Problem. A registration dossier assembled without the manufacturer stalls on construction and material questions.
How it works here. Tell us the destination market and we will confirm what product documentation is available for the articles you are registering.
Process Control
Problem. A quality system that only exists on paper shows up as variation in the third delivery.
How it works here. Cutting, sewing, gluing, pressing and packing all run in-house across more than 160 types of equipment, so the process being controlled is the process being audited.
Inspection Records
Problem. A quality complaint with no production record behind it cannot be closed.
How it works here. Inspection happens before pairing and packing under the certified system, with technical staff on site.
Export Paperwork
Problem. Documentation improvised per shipment is what holds containers at the border.
How it works here. We already ship to the United States, Germany, the United Kingdom, Australia and Japan, so the export set is routine rather than new.
Ongoing File Maintenance
Problem. Certificates expire quietly and the supplier file goes stale.
How it works here. Ask for current copies whenever your audit cycle needs them rather than chasing them at renewal.
Articles in Scope
Products This Applies To
FAQ
Questions Buyers Ask Before Ordering
What certifications does Da Gao hold
ISO 9001:2015 and ISO 13485:2016 quality management system certification.
Does ISO 13485 mean the products are CE marked or FDA cleared
No. ISO 13485 is a quality management system standard for medical device manufacturers. CE marking and FDA clearance are separate, product-specific processes.
Can you register the products in our market for us
Market registration is handled with the buyer, who normally holds it in their own market. Tell us the destination market and we will confirm what documentation we can provide towards it.
Can we audit the factory
The site is at Building 1-3, Lane 128, Humin Road, Zhuanqiao Town, Minhang District, Shanghai. Contact [email protected] to arrange a visit or an audit.
Which markets do you already export to
The United States, Germany, the United Kingdom, Australia and Japan.
How long has the site been producing medical products
Since 1995, specialising in external fixators, shoulder fixators, orthopaedic supports and post-operative rehabilitation footwear.
Quality System and Export Documentation
Send the article list and the requirements. You get an answer against your own list rather than a brochure.