MAE Group
We’re Growing! MAE Consulting Expands to Europe

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
Changes expected with the Indian Medical Device Regulations

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 Truth About Planning in Project Management

The Truth About Planning in Project Management

Have you ever had to go to a meeting to try to explain why your project is delayed? Remember the knot in your stomach? As you are taking the last few steps down the corridor to enter the conference room…
Marketing Your Medical Device Globally and Export Compliance

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.
“As a client of MAE Group, we have contracted with them for multiple projects which were always done professionally and on time. We especially were impressed with their overall knowledge of the regulatory field and their structured and communicative approach to the projects at hand”
Mark J. Lewis VP Operations and RA HydroCision Inc
“MAE Group has evaluated and provided guidance on all aspects of regulatory strategy for our product development. They are a very proactive group that knows time is money, that is why their responsiveness is highly effective. MAE Group has a deep understanding of IVD regulatory, and we look forward to pursue regulatory approval with them.”
Gonzalo Ladreda CEO POCKiT diagnostics

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…

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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…

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Resources

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

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“Neopenda has enjoyed working with MAE Group. Their thoughtful approach and expertise has enhanced our product development efforts and has given us confidence in our ability to deliver high quality products. The team's responsiveness and ability to accommodate new challenges and questions is impressive.”
Sona Shah CEO & CO-Founder Neopenda