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