Pericoach – Analytica

The PeriCoach combines a sensor, smartphone app and cloud-based data management to help women successfully strengthen their pelvic floor muscles. It guides your training and monitors your progress. Blue curve worked with Analytica to take the PeriCoach from prototype through an extensive safety and regulatory process to manufacturing and successful FDA certification.

• Full design description documents
• Full technical file documentation
• Risk assessment to ISO14971
• Safety testing planning and management for multiple IEC standards, including IEC 60601-1
• Useability engineering to IEC62366
• Biocompatibility Assessment to ISO 10993
• Tech files for CE and FDA approval