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For the most part, everyone in the medical device industry is familiar with the term “510(k)”, but not many people ...
FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) released a ...
On May 5, 2017, the Active Implantable Medical Devices Directive (90/385/EEC -- AIMD) and the Medical Devices ...
As FDA begins to restart on-site inspections of domestic and foreign sites, Health Canada on the other hand has ...
With the recent pandemic, one of the most crucial medical services is that of Digital Medicine. It is the merger ...
Internal audits are a critical activity for every medical device firm. Not only are they mandatory per 21 CFR ...
Hand sanitizers in Canada are regulated by the Natural and Non-Prescription Health Products Directorate (NNHPD). ...
One of the widely accepted software design patterns is the Waterfall model in which all activities, starting from ...
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) is taking big steps to deal with the pandemic ...
One of the backbones of the current Industry 4.0 is Artificial Intelligence (AI). It is the process of simulating ...
Bingham Farms, MI, August 12, 2020 –Inc. magazine today revealed that E.M.M.A. International Consulting Group, ...
Medical Device user fees are something all medical device firms should be well acquainted with. Under the user fee ...
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