REGULATORY COMPLIANCE

Quality Management System

ISO 13485 quality system certification

ISO 13485:2016 certification

US FDA (21 CR Part 820) compliance

We are fully compliant with the US FDA Quality System Regulation. View our Establishment Registration on the FDA website

Notified Body / Registrar / Certification Body

JointPoint, Inc. maintains MDSAP ISO 13485:2016 certification and is audited every year by:

Intertek

Intertek Testing Services NA, Inc.
900 Chelmsford Street
Lowell, MA, USA 01851
Telephone: +1.800.967.5352

Product Certification and Approvals

CANADA- Medical Device Licenses (Links to Health Canada website)
*coming shortly

UNITED STATES - FDA 510(k) cleared
JointPoint 510k

Global Regulatory Representatives

Shown below are in-country representatives for regulatory affairs issues and incident reporting.

AUSTRALIA - Sponsor
EMERGO AUSTRALIA, Sydney, Australia
Telephone: +61.2.9006.1662
https://www.emergogroup.com/services/australia/australia-tga-sponsor