Medical devices, and the device part of a combination product, must be developed under design control. Without it, you risk a product that does not suit its intended market or that regulators will not approve.
This 60-minute medical device design control training explains the basics and the overall flow of the design control process, including the regulatory requirements from both the FDA and CE mark perspectives.
The session focuses on design inputs, the foundation of the process: starting with user needs, translating them into product requirements, and the next steps that follow.
WHY SHOULD YOU ATTEND?
Understanding design control is both a regulatory requirement and a key to developing devices successfully. Getting design inputs right shapes everything that follows in development.
This session suits quality and regulatory affairs professionals, R&D scientists, and production and technical support staff working on medical devices or combination products.
AREA COVERED
- Overview of design control
- Why device design needs design controls
- Regulatory requirements from the FDA and CE mark perspectives
- The flow of the design control process
- Design inputs: user needs
- Design inputs: product requirements
- Next steps after design inputs
LEARNING OBJECTIVES
- Explain why design control is needed in product development
- Describe FDA and CE mark design control requirements
- Follow the overall flow of design control
- Identify user needs as the starting point of design control
- Translate user needs into product requirements
- Plan the next steps after design inputs
WHO WILL BENEFIT?
- Quality professionals
- Regulatory Affairs Professionals
- R&D Scientists
- Production Personnel and Technical Support Personnel.
Understanding design control is both a regulatory requirement and a key to developing devices successfully. Getting design inputs right shapes everything that follows in development.
This session suits quality and regulatory affairs professionals, R&D scientists, and production and technical support staff working on medical devices or combination products.
- Overview of design control
- Why device design needs design controls
- Regulatory requirements from the FDA and CE mark perspectives
- The flow of the design control process
- Design inputs: user needs
- Design inputs: product requirements
- Next steps after design inputs
- Explain why design control is needed in product development
- Describe FDA and CE mark design control requirements
- Follow the overall flow of design control
- Identify user needs as the starting point of design control
- Translate user needs into product requirements
- Plan the next steps after design inputs
- Quality professionals
- Regulatory Affairs Professionals
- R&D Scientists
- Production Personnel and Technical Support Personnel.