ISO 13485
Medical device quality management system
Certification body
Certifications
Compliance documentation for OEM partners — CE, FCC, RoHS, ISO, and FDA registration.
ISO 9001
Quality management system
Certification body
FDA Registration
Device establishment registration for applicable products
FDA registration record
RoHS Certificate
Material compliance for LED therapy devices
Accredited lab
FCC SDoC Certificate
FCC Supplier’s Declaration of Conformity
Accredited lab
CE / EMC Certificate
EMC conformity documentation
Accredited lab
CE Certificate
Applicable LED therapy device families
Notified / accredited pathway
ISO Quality System
Factory quality system
Accredited lab / notified body
Document available on request.
RoHS Compliance
Material compliance
Accredited lab / notified body
Document available on request.
FCC Documentation
RF / EMC where applicable
Accredited lab / notified body
Document available on request.
CE Declaration Pack
Applicable device families
Accredited lab / notified body
Document available on request.