MedicalMedical Device Moulding
Intricate, high-precision moulds for parts that go into patients' care
Read moreRegulatory Compliance Support
The manufacturing evidence your submission is going to ask for
Sanpin Medical · since 2019
Overview
Processes aligned with global standards so that the manufacturing side of your submission is not the part that holds it up. Quality management at Sanpin Medical is overseen by our French partner, which is how compliance with European and American standards stays consistent, and that partner also assists clients in obtaining FDA and CE certification.
Problems
What This Fixes
- A supplier whose quality records will not survive an audit
- Submissions delayed because manufacturing documentation is incomplete
- European and American requirements being interpreted differently by each vendor
- No clear owner for the quality management system on the supplier side
Benefits
What You Get
- ISO 13485:2016 held by the manufacturing entity, obtained in its first year of operation
- Quality management run by our French partner rather than left to the factory floor
- Assistance for clients in obtaining FDA and CE certifications
- Detailed documentation and accurate reporting maintained through manufacturing
Who For
Suited To
- Regulatory affairs teams qualifying a contract manufacturer
- Companies entering European or American markets for the first time
- Quality teams preparing for a customer or notified-body audit
Scenarios
Typical Jobs
- Supplier qualification ahead of a design transfer
- Assembling the manufacturing evidence for a CE technical file
- Preparing for an audit where environmental control will be examined
Technical
How It Runs
- Processes aligned with international standards including ISO 13485
- Robust quality management system applied across manufacturing
- Detailed documentation and accurate reporting retained as a matter of process
- Partner-managed compliance with European and American expectations
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 | Regulatory Compliance Support |
|---|---|
| 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 Regulatory Compliance Support
Which standards do you work to?
ISO 9001:2015 and ISO 13485:2016 are held by Sanpin Medical. Our processes are aligned with global standards including FDA regulations and CE marking requirements.
Will you support an audit?
Documentation and reporting are maintained as part of the process precisely so they are available when an audit or a submission asks for them.
Can you help us obtain FDA or CE certification?
Our French partner assists clients in obtaining FDA and CE certifications. Tell us which route you are taking and we will confirm what support applies.
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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.