Medical assemblies·ISO 13485 · Class 7 / 8 cleanrooms · ECO flow published
ISO13485-minded housing & assemblies. Quiet assemblies for regulated partners — change control documented, language calm enough for regulatory desks.
Clean posture
Wide benches. Visible lot tags. Process discipline, quietly shown — not staged perfection.
Who we are
Quiet assemblies for regulated partners
Quiet assemblies for regulated partners — change control documented, language calm enough for regulatory desks.
- 01
ISO 13485 posture
QMS language that matches how your auditors ask — not marketing badges.
- 02
ECO on the path
Published change control so revision surprises stay off the line.
- 03
Lot tags on the bench
Visible lot discipline in the clean bay — process shown, not staged.
Change control
How an ECO flows
The certificate date is not enough. Regulatory buyers need the change-control path before they trust the QMS.
- 01
Initiate
Any stakeholder raises an ECO with a documented reason.
- 02
Review
Cross-functional review within five business days.
- 03
Implement
Effective date agreed with the customer — never imposed.
- 04
Verify
First-article after change, report back to the OEM.
Lead assembly
Handpiece Enclosure Set
ISO13485-minded handpiece enclosures with biocompatible resin options. Clean-room assembly with lot-controlled documentation.
Learn more →Also on the bench
Cart Electronics Module
Shielded electronics housings for mobile medical carts. EMI gasket grooves and documentation sets for 510(k) supporting files.
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Quality posture
What regulated partners review first
- 01
Clean zones
ISO Class 7 and Class 8 rooms with lot-controlled travelers, gowning discipline, and positive-pressure indicators visible on plant tours — not a wall of certificates.
- 02
Biocompatible resins
Options listed by contact type and duration (skin, tissue, indirect) so regulatory teams can evaluate material fit at RFQ — ISO 10993 data per resin family on contract.
- 03
Documentation packs
DHR templates, material certs, and 510(k) supporting-file language available when contracted. Public pages stay light; deep SOPs gate behind NDA for serious reviews.
- 04
Change control
ECO flow published in four steps: initiate, review (≤5 business days), implement with agreed effective date, verify with FAI to the OEM. No silent process drift between lots.
Device class + market
Share regulatory market and device class to start a careful conversation — we reply with process clarity, not a generic brochure pack.
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