MedicalRegulatory Compliance Support
The manufacturing evidence your submission is going to ask for
Read moreMedical Compliance Pathway
For a medical device, the manufacturing partner is part of the submission. This is what sits behind ours: a dedicated medical company certified to ISO...
How We Work
The Shape Of It
For a medical device, the manufacturing partner is part of the submission. This is what sits behind ours: a dedicated medical company certified to ISO 13485:2016 in its first year of operation, a quality system run by our French partner to European and American standards, and direct assistance for clients obtaining FDA and CE certification.
Stages
6 Stages, Each With An Output
A stage is finished when its output exists, not when the calendar says so.
Quality System
ISO 9001:2015 and ISO 13485:2016 held by Sanpin Medical, the entity that manufactures the parts.
Partner Oversight
Quality management overseen by our French partner, which is how compliance with European and American standards is kept consistent.
Controlled Environment
Clean room moulding that covers the moulding step itself, keeping dust, airborne microbes and chemical vapour away from the part.
Documentation
Detailed documentation and accurate reporting maintained throughout manufacturing, because that is what an audit and a submission both ask for.
Validation
Prototyping and testing used to verify the device against regulatory requirements before the submission rather than during it.
Certification Support
Assistance for clients in obtaining FDA and CE certifications through our partner.
Capabilities
What This Draws On
Medical
Injection MouldingClean Room Injection Moulding
Contamination control as a production condition, not a promise
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MedicalMedical Device Moulding
Intricate, high-precision moulds for parts that go into patients' care
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MedicalMedical Prototyping & Testing
Prototypes accurate enough to be evidence, not just illustrations
Read moreQuestions
Medical Compliance Pathway Questions
Which standards apply?
ISO 13485, FDA regulations and CE marking requirements are the standards our medical processes are aligned with.
Who holds the certification?
Sanpin Medical, the manufacturing entity itself, holds ISO 9001:2015 and ISO 13485:2016.
What do you provide for an audit?
Detailed documentation and accurate reporting are maintained as part of the process so they are available when they are asked for.
Start The Conversation At Any Stage
Most customers join with a design in hand. Send it, with the annual quantity, and we will tell you which stage you are actually at.
An engineer replies within 24 hours. Attach a drawing or a 3D file and tell us the annual quantity.