Dec 3 • Katie Cooney & Sharon White
The Hidden ROI of Regulatory and Design Assurance Strategy: Saving Time, Cost, and Sanity
What you’ll learn in this informative Design Assurance webinar
In this session, Sharon White from Aztec Medical explains the “hidden ROI” of taking a structured approach to regulatory affairs and design assurance. She describes how understanding regulatory requirements at a top level, recognising how they apply to a specific device, and developing a clear regulatory strategy can support business planning, funding strategy and the overall development pathway.
She discusses the definitions of a medical device, how intended use drives qualification and how risk classification determines the regulatory burden of proof. Sharon outlines how regulations link to standards and how these standards flow into company processes and quality management systems.
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A key point is that companies are developing two products: the technical product and the technical documentation that forms the regulatory submission. Regulatory strategy provides the roadmap that guides design, testing, standards selection and jurisdictional pathways.
Sharon then explains design assurance and how it demonstrates a controlled and traceable design and development process. She walks through the design and development flow including user needs, design inputs, design outputs, verification, validation and review, showing how each step links to risk management and evidence of performance and safety.
The session concludes with how early integration of design assurance and the quality management system helps avoid rework, reduces cost and supports clearer and better-supported regulatory submissions, with post-market information feeding back into risk management and the technical documentation throughout the device lifecycle.
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Meet Your
Industry Expert
Rod
Beuzeval
Rod brings a wealth of worldwide regulatory knowledge and quality assurance experience to companies wanting to design, manufacture, and market compliant medical devices.
Rod has a bachelor’s degree with first class honours in engineering and management. He also holds the prestigious Regulatory Affairs Certification (Global Scope) from the Regulatory Affairs Professionals Society and is a Lean Sigma Green Belt. Rod has worked in the medical device and pharmaceutical industry for over 22 years, including time spent in some of the largest medical device and pharmaceutical manufacturers.
Rod’s experience has involved providing regulatory strategy from product development to worldwide market registration, creation of technical documentation, implementation of full 13485 compliant QMS systems, standards compliance, clinical evaluations, risk management files, project management and remediation activities. Rod has also spent time working for a notified body, conducting audits against ISO 9001, ISO 13485, 21CFR820, MDSAP, cGMP and GDP.
Rod’s device experience covers Class I, II and III devices, including software as a medical device, drug delivery devices, IVDs, and active implantable medical devices. More recently, Rod has helped clients update their clinical evaluation processes to the requirements of the MDR, updating risk management systems to the latest standard and delivering training on MDR, IVDR, clinical evaluation, risk management, MDSAP and QMS systems.
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About John
John received his degree in Chemistry and Microbiology from University of Ireland, Galway in 1997.
He then began his career in MedTech as a product builder, assembling one of the first vascular stents, from which he quickly moved into the Quality department as a Quality Inspector.
Since that time John has moved up through the Quality & Regulatory ranks to site leadership level, while also working across a wide spread of small, medium and large multi-national medical technology organisations, and with an equally wide spread of different medical technologies.
John is passionate about simplifying quality and regulatory challenges for industry, which consequently led him to set up Atlas Quality in February 2020.
Since setting up Atlas, among other things, John has assisted multiple organisations with Internal Audit, CAPA, QMS, Risk Management and MDR remediations, lectured on Quality Management Systems in ATU, Galway and University of Limerick, and has presented at international conferences on the MDR & Risk Management.
About Aaron
Aaron currently works as the Vice President of Quality Assurance located in Boston Massachusetts. Prior to this, he worked at Fresenius-Kabi, Molnlycke Healthcare, Waters Corporation, Covidien, Cardinal Health, and General Electric. He has worked with a wide range of medical devices from simple class I disposable medical devices to advanced class III surgical instruments, human tissue implants, and sterile IV pharmaceuticals.
He has over 20 years of medical device manufacturing experience which includes 10 years of compliance auditing and 9 years managing quality teams.
He is an experienced trainer that has led multiple training workshops in process validation, CAPA, failure investigation, and quality auditor while at Molnlycke, Waters, and Covidien.
He is an expert in medical device quality management systems and an experienced quality executive.
He has over 20 years of medical device manufacturing experience which includes 10 years of compliance auditing and 9 years managing quality teams.
He is an experienced trainer that has led multiple training workshops in process validation, CAPA, failure investigation, and quality auditor while at Molnlycke, Waters, and Covidien.
He is an expert in medical device quality management systems and an experienced quality executive.
About Richard
Richards’ core skills can be broadly divided into 4 main areas
- Regulatory Affairs
- GMP (Quality Assurance)
- GLP (Laboratory Testing)
- GCP (Clinical)
These core skill areas have been developed over 25 years of experience with products ranging from class 3 devices such as Orthopedic implants (IIb) neurological robots, through electromedical devices such as infusion systems and cardio vascular products.
Richard brings a blend of pragmatism and experience to these disciplines that facilitates insightful problem solving approaches as well as solid solutions.
Richard has also had broad experience in a wide range of materials and manufacturing technologies including sterilisation, plastic moulding, software development, electronic medical devices, ceramics, CNC machining, plasma coatings, packaging, extrusion and automated assembly.
Based on this wealth of experience, Richard is able to support a broad range or services as well as the ability to manage projects on behalf of your organisation.
Richard has also had broad experience in a wide range of materials and manufacturing technologies including sterilisation, plastic moulding, software development, electronic medical devices, ceramics, CNC machining, plasma coatings, packaging, extrusion and automated assembly.
Based on this wealth of experience, Richard is able to support a broad range or services as well as the ability to manage projects on behalf of your organisation.
About Rod
Rod brings a wealth of worldwide regulatory knowledge and quality assurance experience to companies wanting to design, manufacture, and market compliant medical devices.
Rod has a bachelor’s degree with first class honours in engineering and management. He also holds the prestigious Regulatory Affairs Certification (Global Scope) from the Regulatory Affairs Professionals Society and is a Lean Sigma Green Belt. Rod has worked in the medical device and pharmaceutical industry for over 22 years, including time spent in some of the largest medical device and pharmaceutical manufacturers.
Rod’s experience has involved providing regulatory strategy from product development to worldwide market registration, creation of technical documentation, implementation of full 13485 compliant QMS systems, standards compliance, clinical evaluations, risk management files, project management and remediation activities. Rod has also spent time working for a notified body, conducting audits against ISO 9001, ISO 13485, 21CFR820, MDSAP, cGMP and GDP.
Rod’s device experience covers Class I, II and III devices, including software as a medical device, drug delivery devices, IVDs, and active implantable medical devices. More recently, Rod has helped clients update their clinical evaluation processes to the requirements of the MDR, updating risk management systems to the latest standard and delivering training on MDR, IVDR, clinical evaluation, risk management, MDSAP and QMS systems.
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About Katie
Katie has over 22 years of experience in the Life Sciences industry, beginning her career as a production operator at Boston Scientific at the age of 19. She advanced through roles including production trainer and L&D Specialist before transitioning to positions with other notable companies such as Integer and Astelas Pharma, where she served as Site Training Manager and Global LMS Specialist.
Prior to founding Leap Compliance, Katie spent two years as the General Manager of a MedTech QA/RA training company. Katie holds a degree in HR and a diploma in Leadership and Executive Coaching.
Throughout her career, she has exceled in various leadership and HR roles, where she has co-designed and implemented company values and competencies.
Her expertise includes developing competency frameworks, coaching, mentoring, training design and establishing training processes. Katie is an experienced instructional designer and has created multiple training programs from soft skills to technical and compliance training in various formats including virtual, classroom, eLearning and blended programs.
Her expertise includes developing competency frameworks, coaching, mentoring, training design and establishing training processes. Katie is an experienced instructional designer and has created multiple training programs from soft skills to technical and compliance training in various formats including virtual, classroom, eLearning and blended programs.
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