About
What regulated OEM partners dig into first — clean zones, biocompatibility lists, documentation posture, and how change control actually runs.
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.
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.
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.
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.
Change control
Any stakeholder raises an ECO with a documented reason.
Cross-functional review within five business days.
Effective date agreed with the customer — never imposed.
First-article after change, report back to the OEM.
ISO 13485 · Class 7 / 8 cleanrooms · ECO flow published