Barbara Whitman, Regulatory Affairs Manager Barbara has over 22 years of Regulatory Affairs and Quality Assurance experience in the medical device industry. She has worked with companies ranging in size from start-ups to large corporations, developing regulatory strategies for new and existing medical devices. Barbara has authored domestic and international submissions, obtaining global market clearances …
Janet Kwiatkowski, CEO, found MAE Group in in 2013 in order to provide innovative and life saving devices to the world, yet it’s become so much more. 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, …
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 …
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 …
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 »
