Personal Kinetigraph – Global Kinetics

The Personal Kinetigraph (PKG) is worn like a wristwatch to record movement that assists doctors in the treatment and diagnosis of movement disorders such as Parkinson’s Disease. The PKG provides an objective recording system for movement disorder symptoms. Blue Curve has worked closely with Global Kinetics across the design, manufacturing and product regulatory compliance phases of the project, leading to successful CE and FDA certification.

• Risk assessments to ISO14971
• Safety test planning for multiple IEC standards, including IEC6O601-1
• Usability engineering to IEC62366
• Submission write-up for FDA 510(k) clearance
• Biocompatibility Assessment to ISO 10993