MAE Group offers target services and expertise that translate into an efficient and economical fast-track to global markets. Whether your company is your company is experiencing a bandwidth shortfall or you need a specific skill set, MAE Group offers you that expertise. Trust MAE Group to handle every aspect of independent regulatory, quality systems, design […]
Blue Chip Solutions Read More »
Solutions
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 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
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