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 […]
Goal To determine the gaps in documentation between the existing CE Technical File (and other historical design documents) and the requirements of a design history file (DHF) Background A global premier health care company provides products and services for renal dialysis has designed and manufacturers a therapy system for continuous renal replacement therapy (CRRT), intended
Mapping the Path to FDA Clearance: MAE Group’s DHF Compliance Efforts in Renal Dialysis Read More »
Regulatory Affairs, Success Stories
Goal The project goal was to secure CE Marking for a Molecular Breast, Imaging medical device according to the European Medical Device Directive. Background A US medical device company developed a molecular breast imaging therapy system used as an adjunct to standard mammography that measure and image the distribution of radionuclides to aid in the
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
Recall Resolution: MAE Group’s Strategic Approach to Knee Brace Safety Read More »
Regulatory Affairs, Success Stories
Being different makes a difference. That’s why I began MAE Group, to use my own outside-the-box thinking to help others bring life-saving devices into the world. In other words, bring purpose into my business. In the climate of innovation in the health and medical device industry, thinking outside the box as a service provider matters.
Being Different Makes a Difference Read More »
News & Blog
MAE Consulting Group of the United States and now the United Kingdom, is a business service provider specializing in offering domestic and international regulatory, clinical and compliance services to healthcare companies. With expertise in commercializing medical and in vitro diagnostic devices, MAE Consulting can market your product globally and across the Atlantic — in either direction. The new MAE office
We’re Growing! MAE Consulting Expands to Europe Read More »
MAE Consulting International
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);
Changes expected with the Indian Medical Device Regulations Read More »
Educational/Training, International Government Regulations
For a while I had been thinking about starting my own business, partly because I thought I could be successful and partly because I never quite fit with the corporate structure. So when the opportunity presented itself, I decided to dive into the deep side of the pool. It was actually a relief as I
Square Hole in a Round Peg Read More »
Educational/Training
Posted By: By Donna Mitchell-Magaldi, Nerac Analyst On March 20, 2010, the revised Guideline; MedDev 2.7.1 Rev 3 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies became a requirement for obtaining and maintaining a CE Mark for all classes of devices marketed in the European Union. An important component of the MedDev 2.7.1 Rev
The Importance of Article Selection for Meeting the MedDev 2.7.1 Rev 3 Requirements Read More »
Resources
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
Drugs and Biologics in Cosmetics – Who’s Paying Attention? Read More »
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