Regulation

Navigating Regulatory Complexities: MAE Group’s Strategy for Market Entry with a Mobile Medical App

Goal Project goal was to research and determine regulatory strategy to market a mobile medical app as a diagnostic aid to determine level of cognitive functioning. Background A European startup company developed a mobile device app known as Standardized Mental Capacity Assessment. This app is intended as a diagnostic aid to determine level of cognitive […]

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Regulatory Affairs, Success Stories

Recall Resolution: MAE Group’s Strategic Approach to Knee Brace Safety

Goal The project goal was to lead the global recall of Post-Operative Knee Brace medical device Background A US-based orthopedic rehabilitation products company designs and manufactures, a knee brace intended to control the range of motion at the knee joint following surgeries and other structural repairs. Due to a failure in the mechanical hinge, the

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Regulatory Affairs, Success Stories

Changes expected with the Indian Medical Device Regulations

The government of India is planning to develop an in-depth regulatory framework for medical devices. The current system lacks distinctive regulatory system and medical devices are either regulated as drugs or are unregulated. Medical devices that are regulated are under the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO);

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Educational/Training, International Government Regulations

Drugs and Biologics in Cosmetics – Who’s Paying Attention?

According to the Food and Drug Administration’s (FDA) website, “FDA’s legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologics, and medical devices. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. However, FDA may pursue enforcement action against

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