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Laying out a regulatory strategy for your product that visualizes the steps taken to bring a new or modified ...
The FDA released two final rules surrounding the classification, and the requirement to submit a pre-market ...
Farmington Hills, MI, January 16, 2020 –E.M.M.A. International Consulting Group, Inc. (EMMA International), a ...
Recently, 3D printing technology has seen a boom in popularity among many different industries, including medical ...
Certification is a formal recognition of the contributions of women in FDA compliance consulting at EMMA ...
The transition to the new EU MDR and IVDR tops the list this year with the concerns and confusion it continues to ...
The updated version of ISO 14971, Application of Risk Management to Medical Devices, has officially been published ...
The up-classification of devices under the new EU MDR has definitely put some manufacturers in a very difficult ...
The new EU Medical Device Regulation (MDR) was published in the Official Journal of the European Union on May 5, ...
ISO 13485:2016 emphasizes a risk-based approach to the entire QMS, shifting from the traditional risk approach ...
For manufacturers of medical devices, it can be an easy trap to fall into only focusing on the compliance of your ...
The new European Medical Device Regulations and the In Vitro Diagnostic Devices regulation have a lot emphasis on ...
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