About Accumedix
Accumedix Mission
Accumedix Develops and Commercializes New Medical Device Technologies. We intend to generate an excellent return for our investors by providing outstanding value for our customers. We will continue to grow the company through constant development of our quality and manufacturing services and compliance with regulatory requirements. We will maintain a friendly, fair and creative work environment that respects people, process and creativity. Our motto is, “Doing well by doing good.”
Our Business
Accumedix has been in operation since 2001 and is located in Libertyville, IL. The Accumedix facility is FDA registered and has obtained ISO MDSAP and ISO 13485 certifications for European Notified Body, UL, Medical Device Directive and FDA Quality System Reg. 21 CFR Part 820.
Who We Are
Paul J. Serio, President contact Paul at: paul.serio@accumedix.com
Paul Serio has over 30 years experience in general management, information technology, R&D, operations and project management in the medical device industry. He has been a senior executive with Baxter Healthcare and Fenwal Blood Technologies.
Most recently, he led the IT acquisition team performing due diligence, negotiating and managing a global transition services agreement that created Fenwal Blood Technologies as a separate company. He led the implementation of SAP in 13 countries in 12 months.
He has led many global initiatives including other divestitures, acquisitions and startup operations. Mr. Serio has a B.S. degree in Biology from Marquette University.
Michele H. Kupcso, Vice President Quality Operations
Michele Kupcso is the President of Vantage Consulting International, Ltd. Ms. Kupcso has over 30 years of quality, regulatory, customer service and project management experience with various divisions of Baxter Healthcare and Allegiance Healthcare.
She has directed responsibilities in Medical Device Quality System Requirements (QSR), Design Control, Medical Device Reporting, Recall and Field Corrective Actions, Good Laboratory Practices, Premarket Notifications (510k), European Technical File, New Drug Applications, Investigational Device Exemptions, Quality Audits, Program Management and Customer Service operations. She has been directly responsible for the implementation of multiple quality systems including the first Russian GMP compliant and ISO certified manufacturing operation.
She has been directly responsible for the implementation of design control processes that resulted in the market introduction of over 850 new products within an 18-month period. Ms. Kupcso has a B.S. degree in Biochemistry and Chemistry.
She has been an ASQC Certified Quality Engineer and Certified Quality Auditor, and also has been Regulatory Affairs Certified, (RAPS). She is a member of American Society of Quality Control, Regulatory Affairs Professional Society and the National Association for the Education of Young Children.
Charles C. Smith, Consulting Services
Charles Smith has over 30 years experience in manufacturing, quality assurance and regulatory compliance for both the drug and medical device healthcare industries. He has knowledge and expertise in the assessment and implementation of domestic and quality systems compliant with GMP, ISO 9000 and the European Medical Device Directive.
He has extensive knowledge and experience in aseptic processing manufacturing techniques, controlled environment qualifications, process validations for both drug and device manufacturing processes, aseptic liquid and powder filling, and computer controlled lyophilization systems.
Mr. Smith is knowledgeable in the Drug GMP’s, Medical Device Quality System Requirements (QSR), ISO 9000, Medical Device Reporting, Recall and Field Corrective Action, Good Laboratory Practices, Equipment Calibration and Design Control.