MAE Consulting Group – Regulatory. Compliance. Knowledge.

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…

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

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…

MAE Consulting Group is a business service provider specializing in domestic and international regulatory affairs and compliance services to healthcare companies to commercialize medical and in vitro diagnostic devices in target markets.

Services & Experience

MAE Consulting 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 Consulting Group can assist your…

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About us

Janet Kwiatkowski has over 15 years of Regulatory Affairs and Compliance leadership and experience at Fortune 500 and start-up companies. Janet is experienced at developing and successfully implementing global regulatory and compliance strategies for medical devices, in vitro diagnostic devices and…

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Presentations

PDFs: Understanding International Med Device Reg Process – 2013 Going Global: Commercializing Your Life Sciences Innovation Around the World – 2014 MAE Consulting Group Lunch & Learn – 2014 Audio: International Med Device Spotlight Radio Inteviews: December 26, 2013; January 20, 2014; February…

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MAE Consulting is pleased to announce that Yashesh Himanshu Rawal has joined MAE Consulting Group. Yashesh will focus in global regulatory affairs including pre-market activities, writing and submitting product applications and post market vigilance activities. Yashesh holds Bachelor of Science Degree in Pharmacy and Master of Science Degree in Regulatory Affairs for Drugs, Biologics and Medical Devices.

You can contact Yashesh at Yasheshr@maeconsultinggroup.com or 603-452-7433 X102

MAE Consulting Group, LLC Adds Strategy and Business Development Lead

Manchester, NH – MAE Consulting Group, LLC (www.maeconsultinggroup.com) is pleased to announce the addition of Steve Ives to lead strategy and business development. Ives brings more than 25 years of experience helping emerging companies achieve rapid growth. He will further develop MAE’s vision as a strategic business partner navigating medical device companies through the regulatory, clinical and compliance process, from concept to final approval to profits.

Steve Ives has a wealth of experience advising companies that have created sophisticated solutions using complex development processes. “I’m excited to start a new challenge at MAE Consulting Group where the emphasis is on developing and executing a strategy that ensures regulatory and financial success,” Ives said. Read more