Injection MouldingClean Room Injection Moulding
Contamination control as a production condition, not a promise
Read moreMedical Device Moulding
Intricate, high-precision moulds for parts that go into patients' care
Sanpin Medical · since 2019
Overview
Production of intricate, high-precision moulds for medical devices, run inside a business that exists only for medical work. Sanpin Medical was set up in 2019 with four departments, a 20,000 sqm facility and 260 staff, and took ISO 13485 in its first year rather than years into trading.
Problems
What This Fixes
- General moulders who treat a medical part like any other plastic part
- Tooling suppliers with no quality system a notified body will accept
- Fluid-path geometry that a general tool room has never had to hold
- Programmes stalled because the supplier cannot produce the records
Benefits
What You Get
- A dedicated medical operation, not a medical line inside a general factory
- ISO 9001:2015 and ISO 13485:2016 held by the manufacturing entity itself
- Quality management run by our French partner to European and American standards
- Four departments covering the work from tooling through to controlled-environment moulding
Who For
Suited To
- Medical device OEMs sourcing moulded components
- Diagnostics companies with disposable consumables
- Distributors and brand owners commissioning own-label devices
Scenarios
Typical Jobs
- A fluid-path connector where internal geometry governs flow
- A multi-cavity disposable where every cavity has to be identical
- A device housing that has to survive a validated cleaning cycle
Technical
How It Runs
- High-precision tooling for intricate medical geometry
- Clean room moulding available for the parts that require it
- Compliance with European and American standards through partner-managed quality
- Assistance in obtaining FDA and CE certification
At A Glance
Specification
Everything below is published because it is what an engineer checks before sending a drawing. Anything not listed is confirmed in the quotation rather than guessed at here.
| Capability | Medical Device Moulding |
|---|---|
| Group company | Sanpin Medical, established 2019 |
| Category | Medical Device Manufacturing |
| Location | Shenzhen, Guangdong, China |
| Certification | ISO 9001:2015 / ISO 13485:2016 |
| Post-treatment | Plating, Anodizing, Painting, UV printing, Screen printing |
| Response time | Engineer replies within 24 hours |
Order Process
How This Job Would Run
The same eight stages apply whether the order is a single tool or a production programme.
Request A Quote
Send the part drawing or 3D file by email. An engineer comes back within 24 hours with a consultation, not an auto-reply.
DFM Report
Before any steel is cut we return a design-for-manufacture report that flags flaws and errors in the design, so they are fixed on paper.
Mould Design & Moldflow
A predictive model analyses how the molten material behaves inside the cavity. Flow analysis settles gating and cooling before tooling.
Mould Tooling Production
Tooling is cut from the steel grade chosen for the application, not from whatever is on the rack.
T1 Sample Inspection
First-trial samples go out for your inspection and review. Errors are identified on T1, before mass production is committed.
Low Volume Production
A low-volume run follows the trial phase, so precision is proven on real machines under expert surveillance before the ramp.
Strict Inspection
Parts are inspected against international tolerance standards and against the specification you supplied.
Delivery
Parts are packaged to survive the journey and released through our logistics partners on a scheduled delivery.
Questions
About Medical Device Moulding
Which certifications does the medical operation hold?
ISO 9001:2015 and ISO 13485:2016. Sanpin Medical obtained ISO 13485 in 2019, the year it was established.
Who manages quality?
Quality is overseen by our French partner's management, which is how compliance with European and American standards is kept consistent.
Can you help with regulatory approval?
We assist clients in obtaining FDA and CE certifications. Tell us which market you are entering and what evidence you need from the manufacturing side.
Related
Often Quoted Together
Injection Moulding
Medical
MedicalRegulatory Compliance Support
The manufacturing evidence your submission is going to ask for
Read moreFurther Reading
Related Articles
KnowledgeWhy Clean Room Injection Moulding Matters In Medical Device Manufacturing
In medical device manufacturing, cleanliness and precision are not separate requirements. Clean room injection moulding is where both are decided.
Read moreKnowledgeEnsuring Regulatory Compliance In Medical Manufacturing
Regulatory compliance is what confirms that a medical device meets the safety and quality standards it claims to. It is a manufacturing question as much as a paperwork one.
Read moreKnowledgeCustom Medical Components: Tailoring Solutions To Specific Needs
Custom components address specific needs and improve patient care. A catalogue part always forces a compromise; the question is who ends up carrying it.
Read moreGet This Quoted
Attach the drawing or the 3D file and tell us the annual quantity. An engineer replies within 24 hours with a consultation.
An engineer replies within 24 hours. Attach a drawing or a 3D file and tell us the annual quantity.