Welcome to Medicept

Mark Cox: AlvaMed President, Founder

Mark Cox has 20 years of experience helping clients throughout North America and Europe value technologies, and develop and introduce new medical products. His expertise includes due diligence management, technology transfer and licensing, IP valuation and strategy, and product cost analysis. Mark has led or contributed his expertise to more than 20 due diligence efforts, and his cost-analyses and opportunity identification efforts have saved clients as much as $10 million annually on a single product line.

Mark founded AlvaMed in 2003 to provide consultation services to medical device companies throughout the product lifecycle. Before founding AlvaMed, Mark spent 16 years as a consultant, most of which were with Arthur D. Little.

Mark holds a BE in Metallurgy and Materials Science from Imperial College, London, and an MS in Materials Engineering from MIT.

Christine Vozella: 25+ Years of Regulatory and Quality Compliance Success

For more than 25 years, Christine Vozella has been successfully guiding companies through every step of the Regulatory and Quality Compliance processes, both in the U.S. and abroad.

Ms Vozella has authored numerous 510k and IDE submissions, prepared and presented to FDA at pre-IDE meetings, and developed labeling and submission strategies. She has also conducted regulatory due diligence for medical product acquisition, helped companies establish ISO compliance to obtain CE marking, and successfully managed both FDA and Notified Body audits. In addition, Christine’s QSR/ISO 13485 audits for companies with class II and III medical devices have consistently resulted in continuous improvements in both products and processes.

Prior to joining AlvaMed, Christine served as Sr. Director of Regulatory Affairs and Quality Assurance at Aspect Medical Systems. Previous positions include Manager of Regulatory and Compliance at St. Jude Medical, Regulatory Affairs Manager at C.R. Bard, and Regulatory Specialist at Kendell Company.

Christine earned a Masters in Public Health from Boston University and graduated Cum Laude with a BS in biology from Fitchburg State College.

Brian Connolly: Driving Ongoing Improvement in Design Control System

Brian Connolly offers AlvaMed clients more than 20 years of medical device development experience, ranging from complex hardware/software systems to single-use disposables.

Since 1997, Brian has been leading development and ongoing improvement of Design Control systems, with a focus in software development. In product development leadership roles with Hewlett Packard (now Philips) Patient Monitoring, Abbott Diabetes Care, and Arrow International Cardiac Care, Brian created and implemented production strategies aimed at meeting budgetary requirements and challenging time constraints while maintaining strict product quality standards.

Mr. Connolly earned a Masters degree in Engineering Science and a BS in Physics and Engineering from Loyola University. Brian has authored three US patents, two in diagnostic instrumentation and one in data communication.

Dr. Robert Ezzell: Scientific Knowledge and Regulatory Expertise Guiding the Product Lifecycle

Dr. Robert Ezzell brings 20 years of product development and regulatory experience to AlvaMed, with a focus in medical devices and diagnostic technologies. He has held senior-level positions at firms developing a variety of therapeutic and diagnostic technologies.

Appling both his scientific knowledge and regulatory expertise, Dr. Ezzell has guided numerous medical products through the lifecycle, from development and phase I and II trials, through market introduction.

Dr. Ezzell has held faculty positions at Harvard Medical School, establishing a well-funded research laboratory and authoring 60 scientific publications.

Ezzell earned a Ph.D. in Molecular Biology from UC Berkeley, a BA in Microbiology from UCLA, and an MBA from Northeastern University. He received his RAC (Regulatory Affairs Certification) through the Regulatory Affairs Professional Society.

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