Certificates & Compliance

Download regulatory certifications and compliance documentation

Certifications & Compliance Documents

Access our regulatory certifications and quality documentation

CE Mark Certificate

FDA Clearance

UKCA Certificate

ISO 13485:2016 Certificate

Medical devices quality management system certification

ISO 9001:2015 Certificate

Quality management system international standard

ISO 9001 :2015 Certificate

Quality management system international standard

Electrical Safety Certification (IEC 61010)

International electrical safety standard compliance

EMC Compliance Certificate

Electromagnetic compatibility certification

RoHS Compliance Declaration

Restriction of Hazardous Substances compliance

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