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E.M.M.A. International Consulting Group, Inc. Announces Participation in the Medical Devices: FDA Regulation in the Era of Technology and Innovation Panel

E.M.M.A. International Consulting Group, Inc.(EMMA International) a global leader in quality, regulatory, and compliance services for the Medical Device industry, will be participating in a panel discussion on how FDA has taken steps to keep up with the continuously growing digital device field. Also, EMMA International will be delivering a course on the post-market activities that Software as a Medical Device (SaMD) manufacturers should follow.

Both the discussion and course will be great platforms to understand and gauge the challenges faced by the medical device industry in bringing their digital device to the market as well as hear some success stories.

The discussion will focus on the new proposed regulatory framework regarding Artificial Intelligence/ Machine Learning based SaMD. This is a new and exciting topic as FDA released the proposed regulatory framework on April 5th and this will bring about the chance to discuss different opportunities and challenges that may occur with the potential new regulations.

The course is focusing on the key principles to consider during post-market surveillance of SaMD. It goes into detail on quality management systems, recalls, continuous improvement, and much more. If you are wondering what post-market issues you should be considering regarding software, this is the course for you.

“I am very excited about speaking at the panel and delivering the course. As medical device consultants, we have experienced companies struggling to comply with the requirements for the software. This course and discussion will give the industry an insight into how FDA regulates devices in the software world.”, stated Dr. Carmine Jabri, President and CEO. “We are looking forward to sharing our perspective and experiential learnings with everyone”.

About E.M.M.A. International
E.M.M.A. International Consulting Group, Inc. (EMMA International) is a global leader in compliance consulting and enterprise quality management software solutions. Headquartered in Farmington Hills, MI, with offices in FL, NC, PA, India and MENA. We focus on quality, regulatory, and compliance services for the Pharmaceuticals and Medical Device industries.

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