Regulatory Compliance

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Regulatory Compliance

We guide manufacturers through the process of meeting regulatory requirements in usability (or human factors) engineering in different global regions.

By simplifying the steps, we can help your organisation scale the effort into usability engineering in order to make best use of time and resources.

We can help manufacturers establish a usability engineering process, as required in IEC 62366, develop a usability engineering file for notified bodies in Europe, and also prepare a Human Factors Engineering report for the FDA.

We also offer open enrolment training courses in medical device usability, covering key principles, techniques and documentary/regulatory aspects. Our services are described below.


Developing a Usability Engineering Process

One the key requirements in the IEC 62366 standard is that manufacturers develop a structured approach to usability by developing a usability engineering process spanning the full design and development lifecycle of the product.

We can either review or take an active involvement in any of the following activities:

  • Defining the objectives of, and scaling the effort into, usability engineering
  • Developing a plan and process (e.g. SOP) outlining usability checkpoints, tools, techniques, deliverables, and roles and responsibilities
  • Integrating the usability engineering process with the risk management process to ensure traceability of issues

Once a usability engineering process is established, we can help with user research, UI design, human factors risk assessment, usability inspection and usability testing.


Preparing Documentation for Regulatory Authorities

We can assist with the preparation or inspection of a usability engineering file for notified bodies in Europe and/or a Human Factors Engineering report for the FDA. If you are preparing both documents, we can also assist with linking information together.

We are also familiar with the reasons why pre-market submissions get rejected by, for instance, human factors evaluators in the Office of Device Evaluation (ODE), due to human factors deficiencies. We can therefore ensure that your submissions do not encounter similar problems.


Training in Medical Device Usability

Over the last 2 years, we have trained over 300 delegates from almost 60 different medical device organisations across Europe, including manufacturers, regulatory and notified bodies, and product design agencies.

Our courses provide a comprehensive coverage of usability/human factors requirements in the medical device industry, covering key principles, techniques and documentary/regulatory aspects (i.e. usability engineering file, HFE report in US).

Delegates gain practical experience of usability techniques, such as task analysis, use-error analysis and cognitive walkthrough, and also receive a grounding in how to design and run usability tests, both formative and summative.