Global. Commercial. Partner

We Bring Lifesaving Products to Global Markets.

MAE Group is a business solution provider specializing in domestic and international Regulatory Affairs, Artificial Intelligence and Machine Learning, Quality Systems Management, Design and Development Engineering, and Project Management services to healthcare companies to commercialize medical devices and in-vitro diagnostic devices in target markets.

Our Services​

Global regulatory expertise, quality systems management, AI-driven innovations, and comprehensive design and development engineering – your one-stop solution for successful market launch and growth.

Our Location

250 Commercial Street, Suite 3007, Manchester, NH 03101

Connect with Us

Explore possibilities, align strategies, and drive success. Connect with us for tailored solutions or book a consultation to discuss your unique needs and goals.

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We Employ Latest Research Technology & Company​

MAE Group is the capstone between the inventor and the investor. We offer a full bespoke suite of commercialization services to early-stage companies. Our teams will efficiently get through the commercial process, maximize the inventor’s exit strategy, and de-risk
the investor’s funding exposure. We bring medical device and in vitro diagnostic device technology to global markets, allowing the inventor to focus on science and technology and the investor on portfolio management and ROI.

“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.”

Janet Kwiatkowski,

Founder, and CEO of MAE Group

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Our Expertise​

Since 2013, MAE Group has offered regulatory, clinical, quality management, and reimbursement services to global medical, bioscience, and life science companies. In 2017, we extended support to early-stage medical device firms, guiding them through successful market launches.

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Regulatory Affairs

We are international regulatory experts who advance your innovative medical and in vitro diagnostic devices to the global markets.

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Artificial Intelligence and Machine Learning

We utilize AI/ML and deep learning in medical devices for precise diagnoses, proactive healthcare, data management, remote surgery, and diagnostics.

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Quality System Management

We offer expert guidance tailored to your commercial life cycle, ensuring a smooth transition with a systematic, efficient, and proven approach.

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Design and Development Engineering

We excel in diverse projects, strategic thinking, and complex innovative solutions for effective product development and manufacturing.

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Project Management

We prioritize proficient project management, minimizing delays, controlling costs, and ensuring a secure market introduction—a one-stop solution

Why People Trust Us​

We expertly guide your market entry, deliver comprehensive regulatory solutions, offer full commercialization support, provide a competitive edge for business expansion, and offer a one-stop solution for strategic growth goals.

Market Navigation

Navigates the Path to Successful Market Launch

Go-to-Market Expertise

Delivers a Comprehensive Suite of
Commercialization Solutions

Growth Strategy Hub

One-stop Solution for Business Strategy to Achieving Growth Goals

Competitive Support

Supports Expanding Business with a
Competitive Advantage

What People Say About Us

Discover what people are saying about our ability to transform innovative ideas into impactful realities, making a difference.

Sona SHAH, Neopenda​

“Neopenda has enjoyed working with MAE Group’s 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.”

MAE Group Team​

Driven by passion and united through collaboration, our team thrives on turning innovative ideas into reality, ensuring extraordinary possibilities for those in health care needs.

Janet Kwiatkowski

Janet Kwiatkowski

Founder and CEO, MAE Group

Jennifer Jones

Finance Manager, MAE Group

Aadhi Aadhavan Balasubramanian

AI Engineer/Data Scientist

Darshan Bhaiya

Darshan Bhaiya

Regulatory Affairs Specialist

Jay Shah

Jay Shah

Biomedical Engineer

Prashant Vanani

Regulatory Affairs Specialist

Sanover Tasneem

SM/Digital Marketing Analyst

Advancing Healthcare with MAE Group

At MAE Group, our mission is to drive healthcare forward, making a meaningful difference for patients. Through diverse expertise, innovative approaches, and robust capabilities, we empower customers to achieve better results, leading to improved patient outcomes. Explore how we can help you bring life-saving products to global markets.


250 Commercial Street, Suite 3007, Manchester, NH 03101

Call Us

+1 603-340-7079

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