Services:
Regulatory and Quality Solutions LLC provides full-service regulatory affairs and quality assurance expertise to medical device organizations. Our mission is to navigate the complex regulatory landscape and determine the most efficient paths to a safe and effective product, cleared for U.S. and international marketing. This is accomplished through results-driven, experienced team members providing you with on-site leadership and support in all areas of regulatory affairs and quality assurance. Our services focus on the following:
- Regulatory: Regulatory strategies, FDA 510(k)s, EU Technical Files/Design Dossiers and worldwide registrations. Includes regulatory standards requirements assessment.
- Regulatory Officer Retention: Regulatory Officer to provide guidance to management teams regarding day-to-day regulatory risks and business-balanced decision making.
- Quality System: ISO 13485:2003 and FDA QSR compliant quality system development and training, manufacturing registrations, device listings, and quality system auditing.
- Clinical Trials: Clinical trial strategies including alignment with FDA, and clinical trial management and monitoring.
- Product Quality: Predictable product quality through development of processes for supplier qualifications, supplier quality inspections, part and tool qualifications, and capability analyses.
- Safety Risk Management: Risk management process development to ISO 14971 standard & implementation for new products. Early-stage safety risk assessment for new VC funded products.
- Verification and Validation: Verification and Validation process and tools development, planning and test protocol generation.
- Acquisition Integration Leadership: Acquisition assessments of regulatory and quality aspects as well as integration planning and completion of all regulatory and quality areas.
- Post-Launch Regulatory Support: Development of post-market surveillance processes and ongoing support of associated activities including field safety risk assessments, field corrections, recalls, supplier assessments and FDA inspection preparation and guidance.
- Venture Capitalist Due Diligence: Assessments of medical device companies from the perspective of regulatory, quality system, product safety, product quality, clinical strategy, reimbursement, and other industry-specific processes.
Regulatory and Quality Solutions LLC Service Offerings
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Maria Fagan, President and co-founder of Regulatory and Quality Solutions LLC, was previously employed for many years at one of Pittsburgh’s top medical device companies, MEDRAD, Inc. At MEDRAD, Maria progressively worked into high leadership roles in regulatory and quality assurance. As Manager of Quality Assurance for New Products, Maria led a team of professionals that provided a broad range of quality and regulatory services to product development teams. Maria played an integral part in the development of MEDRAD’s quality system, including writing of the Design Control and Manufacturing Quality procedures that contributed to MEDRAD winning the Malcolm Baldridge award. Maria’s dedication and integrity as well has her ability to develop employees resulted in her receipt of the MEDRAD President Award for Leadership. Fagan most recently operated at MEDRAD as the Director of Regulatory Affairs for the CV SBU and for all European offices. Maria contributed to the successful worldwide launch of MEDRAD Cardiovascular (CV) SBU’s newest injector system, the MEDRAD Avanta.
In Maria’s role in R&Q Solutions, Maria assists companies with using product risk to determine the appropriate level of documentation and requirements.
Maria holds a B.S. in Mechanical Engineering from the University of Pittsburgh.
Lisa Casavant, Vice-President and co-founder of Regulatory and Quality Solutions LLC, has 10 years of industry experience including 4 years at MEDRAD in key roles in the Computed Tomography (CT) SBU. She developed complex regulatory strategies, interfaced to and met with FDA on challenging new products, completed 510(k) submissions, and contributed to the successful worldwide launch of these products. Lisa provided regulatory leadership to new product development teams, and was appreciated for thinking out-of-the-box and making business-balanced decisions. Lisa’s skills stretched beyond Regulatory into post-market product risk assessments and situation analyses. She provided guidance to all SBU’s and manufacturing on assessing risk and responding to field issues. Lisa also has extensive training in facilitation and execution of problem solving, troubleshooting, and rational analysis tools.
Lisa holds a B.S. in Mechanical Engineering from West Virginia University and M.S. in Mechanical Engineering from the University of Delaware.
Bob Markley, Vice President and co-founder of Regulatory and Quality Solutions LLC, was also a co-founder and Vice President of Corporate Solutions, a Pittsburgh-based regional consulting firm that specialized in management and technology solutions for companies, as well as a co-founder and President of Manufacturing Solutions, a value-added reseller of Made2Manage Systems, Inc., developer of the Made2Manage™ Enterprise Business System.
A native of the Pittsburgh area, Bob has been an entrepreneur of numerous local enterprises and has served as a trusted business advisor to local organizations for over 14 years. He has an extensive background in information technology operations and both packaged and custom software applications implementation. He also has substantial experience in strategic and management consulting including business process re-engineering, corporate restructuring, and customer relationship management. Bob earned a Masters of Business Administration from the University of Chicago and Bachelor of Science degrees in Computer Science and Quantitative Business Analysis from the Pennsylvania State University. He resides in Murrysville with his wife and two daughters.
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