HaA PD’s ISO Certification
Overall project management services and consulting services for user-oriented research, human factors and usability, user-interface design, intellectual property, industrial design, product engineering, quality system implementation, and design transfer to manufacturing of medical devices for the global healthcare markets.
We are ISO 13485 certified and have experience using many international standards in our product development, including but not limited to:
ISO 13485 - Quality Management System, Medical Devices
ISO 14971 - Risk Management
ISO 10993 - Biocompatibility
ISO 15223 - Symbols
ISO 11135 - Sterilization
ISO 11607 - Packaging for Terminally Sterilized Devices
ISO 10555 - Intravascular Catheters
IEC 62366 - Usability
IEC 60601 - Medical Electrical Equipment
ANSI HE75 - Human Factors Engineering