MedicalMedical Device Moulding
Intricate, high-precision moulds for parts that go into patients' care
Read moreMedical Device Manufacturing
A separate business, built for medical work only, ISO 13485 certified in its first year.
Overview
What This Covers
Sanpin Medical was established in 2019 and took ISO 13485 the same year. It runs a 20,000 sqm facility with 260 staff across four departments, and its quality system is managed by our French partner, which is how compliance with European and American standards is kept consistent rather than argued about job by job. That partner also assists clients in obtaining FDA and CE certification.
Problems
What This Solves
- General moulders running medical work on a general quality system
- Clean rooms used for packing but not for moulding
- Manufacturing documentation that will not survive an audit
- No support when the submission asks for evidence from the factory
Advantages
What Sits Behind It
- ISO 9001:2015 and ISO 13485:2016 held by the manufacturing entity
- Quality management overseen by our French partner
- Assistance in obtaining FDA and CE certifications
- Four departments covering tooling through controlled-environment moulding
5 capabilities
Everything In This Group
Each page carries its own materials, process notes and the questions buyers ask before they commit.
Medical
Medical
MedicalMedical Prototyping & Testing
Prototypes accurate enough to be evidence, not just illustrations
Read more
MedicalRegulatory Compliance Support
The manufacturing evidence your submission is going to ask for
Read more
MedicalMedical Product Development & Design
Concept to final production, with the regulator in the room from the start
Read moreWho It Is For
Typical Buyers
- Medical device OEMs and diagnostics companies
- Regulatory teams qualifying a contract manufacturer
- Brand owners commissioning own-label devices
Industries
Where It Is Used
Solutions
How We Run It
Questions
About Medical Device Manufacturing
When was the medical operation set up?
Sanpin Medical was established in 2019 and obtained its ISO 13485 certificate in the same year.
Is moulding done inside the clean room?
Yes. The controlled environment covers the moulding step itself, which is where contamination would otherwise be trapped in the part.
Who is responsible for quality?
Quality is overseen by our French partner's management, guaranteeing compliance with European and American standards.
Start With The Part, Not The Process
Send the drawing and the annual quantity. We will confirm which capability in this group fits and what it would take to run it.
An engineer replies within 24 hours. Attach a drawing or a 3D file and tell us the annual quantity.