Regulatory Compliance

In recent years, the FDA has moved to adopt human factors engineering as an important tool in improving the safety of medical devices, including drug delivery devices. Likewise, the EU’s Medical Device Directives now includes requirements for device manufacturers to establish and follow a Usability Engineering Process. Other regulatory bodies, such as Health Canada are following suit.

The push to have medical device manufacturers and pharmaceuticals incorporate human factors knowledge and techniques into their development process isn’t stopping any time soon. Since the FDA moved it’s Human Factors Team into the Office of Device Evaluations, 510(k) submissions for devices and combination products have been rejected because of weak, incomplete, or missing human factors data. For some devices (pumps) the bar is being raised higher still, as new requirements for clinical evaluations have been added.

We help clients understand their human factors obligations across regulatory jurisdictions. We also conduct activities such as Use Error Analysis and Human Factors Validation Testing to help clients meet human factors regulatory requirements.

Solves These Problems

  • The FDA has asked us to conduct a human factors study to support our 510(k) submission. How do we design and conduct a study the FDA will find acceptable?
  • We would like to comply with EN62366 to ensure we meet European regulatory requirements. We need a process, a plan, and a Usability Specification?
  • Historically, our Hazards Analysis has been effective at identifying mechanical issues, but what about use-related issues? How can we control what a user does?
  • How do we go about integrating human factors activities in our development process? What should we be doing given the risk level of our device?

Types of Activities

A la Carte Risk Management. We can conduct specific risk management activities to assist with your product’s development. This includes conducting reviews of the FDA’s MAUDE and MedSun databases for evidence of use-related issues with devices similar to yours, conducting (or participating in) Use Error Analysis (see our Usability and Safety Bench Test™, or reviewing your Human Factors Validation protocol or study results. We also plan and conduct Human Factors Validation Testing for clients, providing a written report suitable for submission to the FDA or for inclusion in your Design History/Usability Engineering File.

Quality System Gap Analysis. We’ll review your Quality System to identify gaps between it and the human factors requirements of FDA’s Quality System Regulation (QSR) and the EU’s Medical Device Directives (MDD). Based on our findings, we’ll generate recommendations for embedding human factors engineering into your product life-cycle.

Human Factors Plan. We’ll develop a plan for human factors activities to support your next development project. We’ll work with you, to create a plan that balances the skills of your team, the costs and benefits of possible human factors activities, and the regulatory requirements given your products level of risk.

Benefits

  • Speeds approval of your device by ensuring human factors requirements are met.
  • Reduces safety risks and legal liabilities.
  • Identifies gaps between your quality system and the human factors requirements of FDA’s Quality System Regulation (QSR) and the EU’s Medical Device Directives (MDD).
  • Establishes a plan appropriate for your projects resources, objectives, and the level of risk for your device.

Deliverables

Our deliverables vary with the activities conducted. In almost all cases, we produce a written report suitable for inclusion in your Design History/Usability Engineering file.