The Design, Development and Industrialization of Medical Devices
This course provides regulatory and quality professionals with a detailed explanation of the elements contained within a well-defined and controlled design process.
Learners will acquire expert insight into the sources of the requirements for a documented design process, including state-of-the-art requirements into specifications, design outputs, design verification, design validation and design transfer. In addition, the design change control process and its interfaces throughout the design process are revealed.
Upon completion of this course, trainees will be able to correctly and successfully:
- Assess the implemented design process whether it meets regulatory requirements
- Plan the design project phases and make assumptions based on facts about the development program of a given medical device
- Communicate efficiently with engineering groups involved in a given design project
- Manage the evidence documents and records throughout the design and development process.
Professionals within the medical device industry, whether inventors, managers, CEO’s or business professionals, who need to understand the elements of the Design and Development process. Engineers that wish to have a refresher on the design and development process. Quality engineers assessing and implementing design and development processes.
Basic understanding of the CE-mark process based on fulfilling the essential requirements from the MDD and/or AIMD. Comprehend the principles of a risk management process. Familiar with either ISO 13485 or 21CFR820 requirements.
For more information on the above knowledge points please see the following courses:
- Clinical Evaluation for Market Approval and Clinical Trials – ID 125
- Risk Management for Medical Devices in EU and US – ID 77
- ISO 13485: Foundation and Basic Principles – ID 196