Industry Challenges
ISO 13485 quality system for diagnostic, monitoring and laboratory equipment.
Regulatory Documentation
Certificates, material declarations and CoC required for audits.
Consistent Repeats
Repeat orders must match the first article exactly, years later.
Hygiene & Coatings
Biocompatible surface finishes and conformal coating considerations.
How We Support You
ISO 13485 System
Dedicated quality plan, device master record and CAPA process.
Engineering Archive
Per-order production parameters archived for exact repeats.
ENIG & Immersion Silver
Flat, solderable finishes suitable for medical assemblies.