What is FSMA? The FDA Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama in 2011. This enables the Food and Drug Administration (FDA) to provide oversight, ensure compliance with requirements, and respond effectively to problems. FSMA also enables the FDA...
Please register for What You Need To Know About The New European Union Medical Device Regulation on Apr 26, 2018 2:00 PM EDT at: https://attendee.gotowebinar.com/register/4765851132747614723 E.M.M.A. International Consulting Group, Inc. is hosting a webinar covering the new EU MDR. Jan Flegeau, Director of Regulatory Affairs, and Dr. Carmine Jabri, CEO, will...
Posted by Stephanie Bouzounis, Senior Communications Specialist Daily consumers use and consume products that have the potential to harm or enhance their health. Medications, food, and medical devices are all regulated by the Food and Drug Administration (FDA). Cosmetics, like these products, are also regulated. Cosmetics,...
Posted By: Stephanie Bouzounis, Senior Communications Specialist The AIDS (Acquired Immunodeficiency Syndrome) crisis in the early 1980s had a profound effect on blood donations. The perception that the blood supply was safe changed in the mind of the public as well as the professionals. Concerns about donors...
Mr. Dahl Brings over 25 Years of Experience in Life Sciences Compliance & Law to EMMA International April 6, 2018, Farmington Hills, MI – E.M.M.A. International Consulting Group, Inc., a global leader in management consulting, welcomes Brian Dahl as the firm’s Compliance Practice Lead. Mr. Dahl...
Mr. Treacy Brings 20 Years of Experience in the Information Technology and Cybersecurity Space to the Life Sciences Industry March 30, 2018, Farmington Hills, MI – E.M.M.A. International Consulting Group, Inc., a global leader in FDA compliance consulting, welcomes Mike Treacy as their Cybersecurity Subject Matter...
Posted By: Stephanie Bouzounis, Senior Communications Specialist Technology and health care have converged in the 21st century under the umbrella of what is known as digital health. What is digital health? The 21st century has seen the convergence of science and technology. This has resulted in the development...
Posted By: Stephanie Bouzounis, Senior Communications Specialist The deadline for the ISO 13485:2016 transition is fast approaching. In less than a year from now, changes will have to be made in order for companies to keep their certifications. Background The International Organization for Standardization (ISO) is a non-governmental entity...
Posted By: Stephanie Bouzounis, Senior Communications Specialist The European Union (EU) published a new Medical Device Regulation in May 2017, giving manufacturers three years before full implementation in 2020. There are several changes in this new regulation. In a whitepaper by BSI titled, “Planning for implementation of the...
Posted By: Stephanie Bouzounis, Senior Communications Specialist Medical devices – like we mentioned in last week’s blog – fall into one of three classes: Class I, Class II, and Class III. Class I devices are low risk, and include over-the-counter items found at a pharmacy such as...