We perform Human Factors research at Formative and Validation stages of medical device/ combination product development, including:
MedHF understands the relevance of Human Factors activities under medical device quality system regulation and has a quality system specialized to medical HF studies.
MedHF offers services for the creation, development and post-market changes of product instructions for use (IFU).
A clear and effective IFU is critical to product success and risk control.
IFU development occurs in concert with the HF and use related risk management process.
Use related risk management is a key part of an ISO14971 compliant HF program. MedHF have significant experience in the application of use related risk management activities at the development and post-market stages of a medical device/ combination product lifecycle.
OUR USE RELATED RISK MANAGEMENT SERVICES INCLUDE:
MedHF has an expert understanding of regulatory requirements and current expectations related to Human Factors Engineering, as well as a wealth of experience in regulatory interactions with Health Authorities and Notified bodies.
WE CAN SUPPORT MANUFACTURERS IN: