MedicalMedical Device Moulding
Intricate, high-precision moulds for parts that go into patients' care
Read moreMedical Devices
Clean room moulding with the records to prove it
Sector
What This Sector Asks For
Medical work has its own company inside the group. Sanpin Medical was established in 2019, holds ISO 9001:2015 and ISO 13485:2016, and runs its quality system under our French partner's management for compliance with European and American standards. Clean room moulding covers the moulding step, not just the packing step.
Pain Points
What Goes Wrong
- Contamination introduced between moulding and packing
- Supplier quality systems that will not withstand a notified-body audit
- Regulatory submissions delayed by missing manufacturing evidence
- Design decisions frozen before manufacturability was assessed
Requirements
What It Takes
- Clean room moulding with the records to prove it
- ISO 13485 certification held by the manufacturing entity
- Support in obtaining FDA and CE certification
- Prototypes accurate enough for validation and user testing
Capabilities
What We Run For This Sector
Medical
Injection MouldingClean Room Injection Moulding
Contamination control as a production condition, not a promise
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Medical
MedicalRegulatory Compliance Support
The manufacturing evidence your submission is going to ask for
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MedicalMedical Prototyping & Testing
Prototypes accurate enough to be evidence, not just illustrations
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MedicalMedical Product Development & Design
Concept to final production, with the regulator in the room from the start
Read moreOrder Process
How A Programme Runs
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
Medical Devices Questions
Do you hold ISO 13485?
Sanpin Medical holds ISO 13485:2016, obtained in 2019, alongside ISO 9001:2015.
Can you help with FDA and CE certification?
Our French partner assists clients in obtaining FDA and CE certifications.
Reading
Written For This Sector
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 moreKnowledgePrototyping For Medical Devices: Why It Matters
Prototyping is a critical step in medical device development. It accelerates the development cycle and makes sure the final product meets every requirement it has to.
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 moreTell Us What The Application Has To Survive
Send the drawing, the material requirement and the annual quantity. An engineer replies within 24 hours.
An engineer replies within 24 hours. Attach a drawing or a 3D file and tell us the annual quantity.