In this webinar hosted from EMMA International's Lead Quality Engineer, Nikita Angane, she will go over the different FDA Centers, as well as the pathways to market, what a RTA (Refuse to Accept) is, and also reviewing labeling, registration, and...
Bingham Farms, MI, June 23, 2020 –E.M.M.A. International Consulting Group, Inc. (EMMA International), a global leader in FDA compliance consulting, has achieved ISO 9001:2015 certification for its quality management system. ISO 9001:2015 is a globally recognized quality management standard developed by...
Bingham Farms, MI, June 12, 2020 – E.M.M.A. International Consulting Group, Inc. (EMMA International), a global leader in FDA compliance consulting, releases a new White Paper covering the impact that the COVID-19 pandemic has had on FDA regulatory policies. COVID-19 has had...
Certification is a formal recognition of the contributions of women in FDA compliance consulting at EMMA International Farmington Hills, MI, January 8, 2020 –E.M.M.A. International Consulting Group, Inc. (EMMA International), a global leader in FDA compliance consulting, is proud to announce...
ISO 13485:2016 emphasizes a risk-based approach to the entire QMS, shifting from the traditional risk approach which is highly product design-focused. ISO 14971-Risk Management for Medical Devices is the gold standard when it comes to applying a risk-based approach to...
The term “cosmeceutical” has become popular in recent years to describe a cosmetic product that claims medicinal benefits. While those in the cosmetic industry use the term to advertise the ingredients and benefits of their products, the FDA does not...
EMMA’s EMEA Regional Director Joseph Yammine explains how the EU’s General Data Protection Regulation applies to the Health Care Industry and how you can prepare your team to follow the regulation and avoid any data breaches....
The Unique Device Identification system is used to identify the device throughout its distribution and use on the market. This system enables efficient post-market surveillance for medical device companies as well as for the FDA. FDA released a final guidance...