July Newsletter

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July's Issue: Successful Strategies for Combination Products 

A message from Melissa Lemke: I am very proud to announce that the Agilis team has been busy this year contributing to numerous human factors engineering publications to share our expertise in regulatory focused combination product and medical device design and evaluation. This month I share some key strategies from one of these book chapters.  Whether you develop combination products or medical devices, I know you will find useful information in this short article that you can apply to your own projects. I look forward to your thoughts on the article and I invite you to get in touch with Agilis to further discuss how we can partner to successfully complete your next human factors project and submission!


Combination products often pose unique design challenges and regulatory authorities have specific expectations regarding human factor submissions. Thus, HF engineering is a critical part of the product development lifecycle and market success. Learn to apply sound human factors processes to medical device design to optimize safety, effectiveness, and overall user satisfaction with a product. Read Now


Let's meet face to face at RAPS Convergence in Philadelphia this September. Email Us


The FDA system of reporting has become more transparent recently. With that transparency the FDA has released over 20 years of records on medical device adverse events. FDA is working to update its Medical Device Reporting program, one of the tools they use to continue to ensure safety in the landscape of health care.  Learn more

We invite you to CONTACT US to discuss how we can be

your trusted human factors partner for the global medical market.

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