Final Days To Register: Intensive 2 Day Introduction To The Design And Development Of Medical Devices Training Course (ONLINE EVENT/ON-DEMAND)
Date
10/15/2024 10:45:45 AM
(MENAFN- GlobeNewsWire - Nasdaq) Dublin, Oct. 15, 2024 (GLOBE NEWSWIRE) -- The "An Introduction to the Design and Development of Medical Devices Training Course" conference has been added to ResearchAndMarkets.com's offering.
This intensive two-day course will introduce those who are new to medical device design and development to the critical elements of the process
It has been designed to provide delegates with an insight into the tools and techniques required to design and develop a medical device and offer an essential overview of the current regulatory landscape. The importance of safety and efficacy will be covered, as will risk management and documentation. As combination products are a huge market, the programme will also address device constituent parts of combination products.
Attending this event will provide delegates with a comprehensive appraisal of key aspects of this process and an opportunity to discuss the complexities involved with an experienced industry expert.
Benefits of attending:
Gain a comprehensive overview of the design and development process Comply with the regulatory requirements and standards Learn about design controls Review materials and biocompatibility Access key information on documentation management and systems Understand how risk should be managed Consider human factors and usability studies
Who Should Attend:
Design and development personnel Development engineers Quality personnel Regulatory personnel Design control professionals Documentation managers Programme managers Anyone who needs an overview of the medical device design and development process
Certifications:
CPD: 12 hours for your records Certificate of completion
Agenda:
Day 1
Overview of the regulations and market routes
Regulatory pathways Medical Device Directive (MDD) vs Medical Device Regulation (MDR) - key differences EU vs US (FDA) - markets to consider Medical device vs combination product (drug/device and device/drug) - which regulation applies? Device classification and the implications for your product Resources and sources
The design and development process
The stages of design and development Key considerations Terminology Intended use Project complexity Mandatory requirements Design and development tools Inspiration, innovation and determination Materials and biocompatibility DFx, Design for....? Manufacturing - key considerations
Day 2
Design control
Appropriate design and development planning Translation of marketing requirements SMART design inputs Is a trace matrix appropriate? Meaningful design outputs Verification and validation Design reviews Design transfer Design history file vs technical file Change control Notified Bodies (NB)
Risk management - what is required?
What is risk management and when should it be applied? What does the guidance say? Help or hindrance? How to implement a practical risk management plan Tools and techniques to help you succeed
Clinical evaluation, human factors and usability - how to comply
Planning your clinical evaluation How to incorporate human factors and usability studies into your design and development process - MDR and FDA requirements User instructions Training considerations - when and who do you need to train? Formative studies Validation/summative studies
Speakers:
David Howlett
Director
PharmaDelivery Solutions Ltd
David Howlett is the Director of PharmaDelivery Solutions Ltd. In 2003 he established the company as a highly specialised consultancy service in the field of drug delivery device technology. This has led to involvement in projects with focus in pulmonary, nasal and other delivery routes, with an international client base. Much of the activity of PharmaDelivery Solutions Ltd is focused in the area of development programme support, regulatory GAP analysis, establishing design control systems and design verification, planning and execution, materials strategies and type III device Drug Master Files (DMFs).
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