FARMINGTON HILLS, Mich.,
May 15, 2019 /PRNewswire-PRWeb/ --
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.
For more information, visit
http://www.emmainternational.com/
SOURCE E.M.M.A. International