Instructors: All speakers are highly qualified and have extensive experience in the medical industry. Experience and credentials include, FDA QSR/GMP, Design Control, Risk, Software, Submissions, Former FDA Investigator & Advisor, European Notified Body, ISO Committee Members, and Specialists in Software Quality Assurance, etc...
Rich Basler A specialist in the Medical Device industry since 1976, Rich has been involved with the Quality function of medical device manufacturing including extensive experience in Quality Assurance, Regulatory Compliance, and Regulatory Submissions for a number of medical device companies. Rich has assisted numerous companies from start-ups to Fortune 100 corporations in developing quality systems compliant with US FDA and International standards, including achievement of ISO 9001 and ISO 13485 registrations. He has assisted numerous corporations in achieving CE Mark approval for their products in the European Union, as well as licensing products in Canada and other countries throughout the World. On the regulatory side, Rich has extensive experience in Pre-Market submissions for new products and for clinical evaluations. His successful submissions span many fields of medicine, including such areas as disposable nasal dilators, implantable and disposable prostate and urological devices, tracheotomy devices and a wide range of laparoscopic access and surgical instruments. A retired US Navy Commander, Rich graduated from the University of California, Berkeley, with a Bachelor of Arts degree and later received a Masters of Business Administration. He is a co-founder and former Board member of the Orange County Regulatory Affairs Group located in Orange County, California. He is a past Editor of the American Society for Quality (ASQ), Orange Empire Section Newsletter, The SCOPE. Rich is a Certified Biomedical Auditor and Certified Quality Auditor under the American Society for Quality.
Corrine Bonfiglio has over twenty years of accomplished quality assurance, regulatory and clinical affairs experience. She offers in-depth experience with FDA & ISO regulatory requirements, including quality system compliance, submissions (510(k), PMA, and CE Marking) and clinical trial development. She assists medical device manufacturers with compliant quality system implementation, auditing and training. Corrine has extensive experience with regulatory strategies and submission of IDE's, 510(k)'s and Master Files as well as import/export approvals for medical devices and biologics. As an international quality system specialist, Corrine has assisted numerous manufacturers to become compliant with the U.S. FDA, the State of
Marc Goodman is a specialist on issues and strategies related to U.S. Food and Drug Administration (FDA) software compliance with emphasis in software verification and validation, software quality assurance, software development procedures, and project planning and management. Mr. Goodman has developed software for critical and non-critical medical devices, manufacturing and test software, laboratory information systems, information systems and work flow control for clinical laboratories, data communications, real-time data base access and many aspects of medical devices for over a 15 year period. Mr. Goodman has consulted on products and processes for all Classes of Medical Devices and Levels of Concern. For over 20 years, Mr. Goodman has pursued software engineering for not only the medical device and FDA related industries but also real-time process control and data communications software development for telecommunications, utilities, and aerospace industries. He is a member of the Institute for Electrical and Electronic Engineers (IEEE) and the IEEE Computer Society. Mr. Goodman holds a Masters in Computer Science and a Bachelors in Economics from the University of Pittsburgh.
David M. MacKenzie has over 25 years of experience in the design and program management of medical, industrial, and aerospace products. He specializes in Hazard Analysis, risk assessment & software safety. Mr. MacKenzie has lectured in conjunction with the FDA on the design of safe microprocessor systems, Hazard Analysis, and the design & validation of international medical products. He is a U.S delegate to ISO/IEC JTC1/SC7/WG9 on Software Integrity and is an ISO Lead Assessor. Mr. MacKenzie has developed validation protocols for products in medical, industrial, and aerospace markets, which successfully led to the introduction of several multimillion dollar product lines. Mr. MacKenzie has designed numerous instrumentation products and developed unique methods for validating software safety. He has worked extensively with domestic and international regulatory agencies, and has established an organization for the design and approval of international medical devices. A member of several professional organizations, including the American Society for Quality Control (ASQC), and the Institute for Electrical and Electronic Engineers (IEEE); Mr. MacKenzie graduated from the California Institute of Technology with a B.S. in Electrical Engineering specializing in Solid State Physics, and has completed graduate work in Integrated Circuit Design at the University of California at Irvine.
Deborah Madsen has over 30 years of experience in the design, manufacture, quality assurance and regulatory compliance of medical and in vitro diagnostic medical devices. Over a period of 21 years, Deborah held several roles at Underwriters Laboratories (UL) including product safety engineer (IEC 61010 and IEC 60601), lead auditor, instructor/trainer, auditor qualifier, and technical file assessor. She conducted audits in accordance with ISO 9001, ISO 13485, implementation of CMDR requirements under the CMDCAS program, Medical Device Directive (93/42/EC), In Vitro Diagnostic Directive (98/79/EC), ISO 14971, and IEC 62304. Over a period of 8 years at Beckman Coulter, Deborah managed the in house product safety, EMC, reliability and product performance laboratory. Deborah also conducted internal audits at Beckman sites world-wide. More recently, Deborah has held roles as Director of Quality and Regulatory for medical device and IVD companies. Deborah holds a degree in Electrical Engineering, and is a Registered Professional Engineer in the state of California.
Stan Magee Stan Magee is president of Software Engineering Process Technology Company, a firm specializing in the implementation of software process technology for U.S. and international corporations and organizations. Mr. Magee is past convener (1999-2002) of WG 7 (Life Cycle Management) for ISO/IEC JTC1 SC 7 (Systems and Software Engineering) standards group. During his tenure the standard ISO/IEC Standard 15288-System Engineering-System Life Cycle Processes, was developed. He was a U.S. delegate to the International Plenary meetings from 1986 -- 2002. In 1995 he was elected to the IEEE Computer Society Golden Core of 500 people who have significantly served the IEEE Society in standards development over its 50 year history. Mr. Magee is co-author of the books, Guide to Software Engineering Standards and Specifications, Artech House Publishers, 1997, ISBN 0-89006-919-0 and Guide to Standards and Specifications for Designing Web Software, 1998, Artech House Publishers ISBN 0-89006-819-4. He has authored many technical reports relating to software engineering standards issues. In 1997 Mr. Magee was part of a “People to People” quality mission to China and lectured at Shanghai University on software quality standards. He gives seminars on meeting the requirements of ISO 9001/9003 for medical device firms. In 1994 he established a software business and quality system plan, for VNIPI Sport of Moscow, Russia for obtaining ISO 9001 certification. VNIPI is the privatized MIS section of the Russian Olympic Committee. In 2002, Mr. Magee established a plan for the Thailand Government to be in the upper quartile producers of software in the world market place by 2010. Mr. Magee has over 42 years experience in the software field and is considered an expert in the area of software life cycle methodology. He is active on many governmental, educational and professional boards, and holds BS from the School of Engineering from Oregon State University and an MBA in International Business from the University of Puget Sound.
Dan Modi is Assistant Director in charge of the Product Certification Group at Alcon Research, Irvine Technology center. He is responsible for directing EMC, Product safety, environmental testing and other validation activities at Alcon. Dan has wide experience in testing, certification, and design evaluation of products for international markets. Dan has considerable experience working with and training on International Standards and Regulations, in order to help manufacturers understand Global Certification requirements. He is a RAC (Certified Regulatory Affairs Professional through Reguatory Affairs Professional Society), NCE (Certified EMC Engineer through National Association of Radio & Telecommunications Engineers) and CQA (Certified Quality Auditor through American Society for Quality). He is Secretary & Education Committee chair of the IEEE (Institute of Electrical and Electronics Engineers)'s EMC Society TC 8 (Technical Committee on Product Safety) and Vice-chair of TC4 (Technical committee on EMC Control). Dan is also a co-author of the MD&DI article "A Primer on IEC 60601-1" published September 2003.
Brent Noblitt is co-founder and Senior Partner of the consulting firm Noblitt & Rueland. Mr. Noblitt specializes in international and U.S. medical device strategic planning, development, and marketing. His consultation has been used to market medical devices throughout the world. Mr. Noblitt's associations range from start-up ventures to Fortune 100 corporations. His marketing background and technical training allows him to comprehend and advise on the marketing planning process and opportunities of various technologies. Prior to founding Noblitt & Rueland, Mr. Noblitt held management & executive positions in the medical device industry. Mr. Noblitts product experience includes various critical care devices, cardiac output computers & pulmonary catheters, extravascular lung water computers, ultrasound devices, phono-angiography, computerized patient databases, patient monitoring systems, disposable & reusable pressure monitoring devices & accessories, ejection fraction computers, continuous mixed venous oxygen saturation systems & catheters, surgical laser systems, implantable defibrillators, pacemakers, continuous blood pressure control systems, as well as, home healthcare delivery systems. His academic training includes a B.S. and M.S. in Electrical Engineering-Biomedical from Purdue University complemented by an M.B.A. degree earned from Pepperdine University and he is a member of ASQC-Biomedical & Healthcare Divisions.
Marcia Page specializes in medical device quality systems and design control systems that are compliant with the Quality System Regulation (QSR) of FDA and International organizations. Her expertise allows her to assist companies with the implementation of compliant quality systems including design control subsystems, perform thorough mock FDA audits, and identify problem areas that create roadblocks to the production of medical devices. She has a vast amount of experience helping a wide variety of medical device manufacturers get their products to the market in a compliant, yet profitable manner. Having over 20 years experience in the quality and regulatory field with a major medical device contract manufacturer and now as Director of Quality for Calypso Medical, Marcia has been intimately involved in the development of Quality Systems which comply with FDA QSR and ISO 9001/9002/13485, EN 46001/46002 including maquiladora operations in Mexico. She has worked with numerous manufacturers in achieving compliance during the manufacture of their products. Marcia has worked closely with FDA, various notified bodies, and has been an invited speaker by the FDA. She has been responsible for Quality Systems that have undergone seven (7) FDA QSR inspections, which have included inspections to the complete FDA QSR design control requirements and the QSIT approach with zero FDA-483 findings or observations. Marcia has been past President and Co-chair of the Organization of Regulatory & Clinical Associates (ORCA), FDA Grass Roots Partnering Committee member, RA/QA committee member for MDMA, and a charter member of the ASQC Quality Audit Division. Marcia attended Washington State University is also a member of RAPS and ASQ professional associations.
Rebecca Pine has over 20 years experience in the medical device industry assisting both industry-leading corporations as well as small business start-ups. She has helped facilitate her clients’ successes by directing and implementing regulatory strategies and executing aggressive project plans. She specializes in gaining U.S. and international regulatory approvals and implementing Quality Systems to assure both domestic and international regulatory compliance. She has significant experience in all aspects of domestic and international Medical Device Regulatory management, including Quality Assurance and Quality Systems. Ms. Pine is an expert in submission compilation and management including 510(k)’s, PMA’s, and CE Mark Technical Files & Design Dossiers. Her background includes Class I, II and III devices in the areas of IVD’s, hemostasis management, cold therapy systems, electro-medical devices (EMS/TENS), infusion pumps, and orthopedics devices including bracing (OTC and Rx), surgical instruments, as well as implantables, brachytherapy and mammography systems.
Christine Posin is a consultant, specializing in regulatory and quality assurance compliance issues in the medical device industry. Chris has over 33 years experience in the medical device industry assisting both large and small device manufacturers. In addition, Chris has also served as a Quality Education Instructor while with Johnson & Johnson. Prior to her career in the medical device industry, she was a health care professional in the respiratory and cardiopulmonary field which gave her valuable hands-on field experience. Chris is active in the Orange County Regulatory Affairs Discussion Group (OCRA). OCRA is a volunteer organization, located in southern California. Their purpose is to provide continuing education to regulatory professionals in the medical products fields. In May 1996 Chris organized a professional network group that focused on medical device reporting (MDR) and international reporting & vigilance, and facilitated this group for over 12 years. The MDR Network Group received the National Performance Review Hammer Award from Al Gore in 1999 as part of his program for innovations in government. Chris has a Bachelor of Science degree from Bowling Green University.
Raymond M. Pizinger has over 20 years experience in the medical device industry including being CEO of a medical device manufacturer. He specializes in international and US regulations which define design controls, CE Mark, software quality assurance, medical device reporting, and vigilance to mention a few. Mr. Pizinger worked with the FDA to implement the first electronic MDR reporting system and assisted the first medical device manufacturer to report MDRs electronically. Per the FDA's request and together with the FDA, he lectured at FDA's conference introducing the MedWatch process and new MDR regulations. He has also lectured on numerous occasions on subjects such as implementing a Quality System, design controls, software quality assurance, medical device reporting, vigilance, and the CE Mark certification process. Mr. Pizinger has implemented multiple Quality Systems that meet the requirements of ISO 9001, EN46001 and FDA's Quality System Regulation. He has also prepared numerous technical files and worked with multiple Notified Bodies to allow products to carry the CE Mark on products intended for the European Marketplace. He has also submitted and gained clearance on numerous 510(k)s, IDEs and has developed and implemented a regulatory review process for determining "510(k) vs no 510(k) required" decisions. Mr. Pizinger is a member of several professional organizations, including the American Society of Quality (ASQ) and Orange County Regulatory Affairs (OCRA). Mr. Pizinger's regulatory and quality experience includes executive management positions for companies producing both electronic and disposable devices including dialysis systems, ultrasonic imaging systems, blood analyzers and RIA devices, invasive blood sensors and catheters, critical care and home care ventilators, new generation sterilizers, cardiac arrhythmia monitors, centralized patient monitoring devices with networks both inside hospitals (LAN) and between hospitals (WAN) systems, interface software and medical telemetry. His academic training includes a B.S. in Biology from the University of California, Irvine, coupled with a minor in Bio-Engineering and graduate work in both electrical and mechanical engineering. His technical training is complimented with an M.B.A. in Management earned from the University of Redlands.
Dennis L. Rubenacker is co-founder and Senior Partner of the consulting firm of Noblitt & Rueland specializing in FDA electronic recordkeeping, design control, risk assessment, software development and software quality management for the medical device industry. He has extensive experience dealing with product development, software development and software quality assurance for medical device instrumentation. Mr. Rubenacker has held software engineering, software quality assurance, electronics engineering, project management, and management consulting positions in the research and development of medical devices, aerospace systems, and consumer electronics. His medical product line experience includes monitoring, diagnostic, and therapeutic critical-care devices. His experience includes clinical chemistry analyzers, immunoassay analyzers, microbiology analyzers, implantable & external defibrillators, glucose monitors, pacemakers, cardiac output computers, ejection fraction computers, oxygen saturation computers, retroperfusion pumps, cardiac imagers, EKG monitors, infusion pumps, catheter-sensor interfaces, home healthcare monitoring devices, as well as, manufacturing process instrumentation. He has been involved with the FDA, Los Angeles district, grass roots partnering subcommittee on electronic recordkeeping and has lectured on FDA electronic recordkeeping with several organizations including the Food and Drug Law Institute (FDLI). Mr. Rubenacker has assisted both domestic and international companies including companies ranging in size from less than $1,000,000 in sales to Fortune 100 companies. Mr. Rubenacker received his B.S. in Electrical Engineering with highest honors from the University of Illinois and is a member of the Institute for Electrical and Electronic Engineers (IEEE), RAPS, OCRA and ASQ.
Christine Ruther has extensive experience assisting the medical device industry with safety critical areas of compliance and regulatory engineering, including the requirements of electronic devices and wireless devices. During her career, Christine was the technical manager for the Medical Device Testing Group while at TUV Product Service, and directly managed the Medical testing and ISO/CE auditing activities for the southwestern region. Her responsibilities included conducting compliance testing for medical devices and performing audits of medical device manufacturers. After four years at TUV, Christine became the Compliance Manager for Cardiac Science in