MAE Group – Global. Commercial. Partner.

We’re Growing! MAE Consulting Expands to Europe

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…

The Importance of Article Selection for Meeting the MedDev 2.7.1 Rev 3 Requirements

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…

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…

Marketing Your Medical Device Globally and Export Compliance

Congratulations – you just received your Clearance Letter from the FDA after months of hard work by a team of dedicated professionals. That Clearance Letter, the CE Marking, and ISO 13485 Certification are the gateway to international markets. You can…

We Bring Lifesaving Products to Global Markets. Global. Commercial. Partner.

Services & Experience

MAE Group is a business service provider specializing in domestic and international Regulatory Affairs, Clinical Affairs, Project Management and Compliance services to healthcare companies to commercialize medical and in vitro diagnostic devices in target markets. MAE Group can assist your company gain…

About us

MAE Group brings lifesaving medical devices to global markets. Founded in 2013, we began by providing global regulatory affairs, clinical affairs, quality management, and program management services to medical device, in vitro diagnostic, bioscience and life science companies to commercialize…

Resources

PDFs: European MDR and CE Transition Strategy – 2019 MAE Group AMD Summit Presentation – 2019 MAE Group Brochure – 2019