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 products in target markets. MAE Group provides these services to start-up and SME (Small and Medium Enterprises) as well as large blue-chip companies.
MAE Group expanded its service in 2017 to offer a full suite of commercialization services to start-up companies, from market research to initial product launch in target markets. MAE Group expertise lies with our in-depth knowledge of regulations and most importantly, interpretation and application of the requirements, to guide any company through the commercialization pathway to successful product launch with strategic and tactical alignment to business plans. Additionally, MAE Group has established good standing with global regulatory bodies.
Janet Kwiatkowski, President & CEO, Founder
Ms. Kwiatkowski, President & CEO, Founder MAE Group, has over 20 years of Regulatory Affairs and Compliance leadership 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 compliance strategies aligned with business and marketing plans. Product portfolio includes Class I, II and III medical devices, companion diagnostics and combination products. Medical specialties include electrical-mechanical systems, disposables, and assays in areas including but not limited to cardiovascular, oncology, infectious diseases, orthopedic, gastroenterology, radiology, obstetrics/gynecology, general and plastic surgery, hematology and immunology.
She has also led organizational transformations, successfully cultivated international business markets, created, and conducted leadership and diversity training programs. Janet also has engineering, operations and business development expertise.
Janet holds Associates of Science Degree in Electronics, Bachelor of Science Degree Mechanical Engineering, Master of Business Administration and Master of Science Degree in Regulatory Affairs for Drugs, Biologics and Medical Devices, minor in International Studies.
Mr. Rawal has ten years’ experience in global regulatory affairs in medical devices (including software as a medical device), project management and quality management systems. Yashesh has experience in writing 510(k) submissions, Technical File submissions, Health Canada submissions, Clinical Evaluation Report for Class II and III medical devices as well as experience in GLP and GMP requirements. Medical specialties include electrical-mechanical systems, disposables, and assays in areas including but not limited to neurology, cardiovascular, infectious diseases, orthopedic, gastroenterology, radiology, general and plastic surgery, general surgery, ophthalmic and hematology.
He has demonstrated ability to provide sound regulatory and quality system strategies, advice, and leadership to product development teams, and to balance regulatory and quality system requirements with ambitious timelines. He has expertise in defining compliance requirements for project teams, ensuring quality management system compliance by providing input and/or updates to procedures as appropriate, ensuring appropriate software development, risk management, and human factors activities, tasks and deliverables are complete. Conduct internal and vendor audits, design control phase gate reviews and all aspects of software product development are covered under design controls, providing regulatory oversight for life-cycle management of released SaMD products.
He also has regulatory experience in biologics, therapeutics, nanotechnology and drugs including development of protocols for pre-clinical and clinical activities, batch formulations, and drafting and implementing procedures in support of anti-cancer drugs and nanostructured lipid molecules loaded with siRNA.
Yashesh holds Bachelor of Science Degree in Pharmacy and Master of Science Degree in Regulatory Affairs for Drugs, Biologics and Medical Devices.