OUR STRENGTHS

We support manufacturers to develop safe, usable and approvable devices by delivering high quality Human Factors services. We are experts in supporting manufacturers to effectively navigate and successfully meet regulatory expectations.

WE PROVIDE:

A solid track record in developing and implementing Human Factors strategies to successfully meet regulatory expectations.

A highly qualified and experienced team with a deep knowledge of Human Factors and Medical Product Development gained through years working for major medical device, pharma companies and regulatory bodies.

An expert understanding of Medical Device Quality System Regulation and quality requirements for Human Factors activities performed under design controls.

Specialized processes to ensure compliance to relevant human subject research and data protection laws/ regulations, including experience in obtaining IRB approvals where applicable.

1. Easier to use devices are safer and more effective – Implementing comprehensive and robust Human Factors processes optimizes device design, which ultimately leads to safer more effective and successful products with lower post-market issues.

2. Meet regulatory expectations – Regulatory expectations continue to grow and manufacturers are subject to increasing pressure and focus to deliver appropriate Human Factors evidence. Failure to implement adequate Human Factors processes can lead to review issues, delays and ultimately non-approvals.

3. Perform compliant Human Factors work: Application of sound GXP principles is essential to ensure data integrity and validity. Human factors data are stored in the Design History File/ Technical File and are subject to audit/ inspection.

MedHF can provide Human Factors support throughout the entire product development process in accordance with Health Authority recognized standards. Our main services include:

  • Human Factors Research (Formative and Summative/ Validation studies)
  • Use related risk management
  • Instructions for use development
  • Expert regulatory support