Phoenix, Arizona (PRWEB) November 03, 2015
Agilis Consulting Group announces the promotion of Melissa Lemke, Medical Device Human Factors expert.
Ms. Melissa Lemke will become a partner in the company as of November 02, 2015. She has worked with Agilis for more than six years. She became Director of Human Factors in 2012. In this role, Melissa oversees all human factors activities with Agilis’ medical device and combination product clients. Under her leadership, all human factors submissions to the Food and Drug Administration (FDA) Center for Device and Radiological Health (CDRH), Office of Device Evaluation (ODE) human factors team have been approved with no challenges.
According to Mary Weick Brady, former Senior Policy Analyst, Office of Device Evaluations, CDRH, FDA, “Melissa’s expert contributions to industry standards committees and panels have helped shape the discussion where it’s most important, on medical device users. I respect her passion for home care and human factors and I believe this passion has made her a recognized leader in these fields.” Jill Schweiger, Vice President, Clinical Studies and Regulatory Affairs with Flowonix commented, “Melissa has been instrumental in helping our company develop and execute a successful human factors testing program that supports the safety claims for our product. Working with our software development team, she streamlined our efforts and kept us focused on the end goal – a product that meets healthcare professional and patient user needs while also achieving FDA and CE Mark approval.”
“We are thrilled to have Melissa join our partnership and be recognized for her past contributions”, stated Patricia Patterson, CPT, President of Agilis Consulting Group.
Ms. Lemke is a biomedical engineer with over 13 years of experience and she is a co-author of ANSI/AMMI HE75:2009 and is helping lead the revision of this industry standard.
About Agilis Consulting Group, LLC
Agilis Consulting Group, founded in 2000, is a privately held company based in Phoenix, Ariz. Through Human Factors Engineering, evidence-based instructional labeling and training, and human factors regulatory consultation, Agilis helps its clients achieve faster regulatory clearance, fewer product liability risks and lower after-sale support costs. Agilis’ clients have reported a 97% improvement in product safety and satisfaction. Clients include Fortune 50 pharmaceutical and medical device companies as well as startups. See http://www.agilisconsulting.com.