Solution
Handpiece Enclosure Set
ISO13485-minded handpiece enclosures with biocompatible resin options. Clean-room assembly with lot-controlled documentation.
Handpiece enclosure sets for diagnostic, therapeutic, and surgical device programs. Biocompatible resin options are listed by contact type and duration — short-term skin contact, long-term tissue contact, or indirect patient contact — so regulatory teams can evaluate material fit at the RFQ stage.
- Resins: PC/ABS for general housings, medical-grade TPU for soft-grip zones
- Biocompatibility: ISO 10993 data available per resin family on contract
- Assembly: clean-room, lot-controlled with traceability to raw material batch
- Docs: DHR (device history record) template available for customer review
- Clean
- ISO Class 8 assembly
- Biocompat
- ISO 10993 by contact type
- Docs
- DHR template on review
- Change
- Locked resin + process under ECO
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