Medical Device Design & Development Control. ISO 13485.

Understand Medical Device Design Control in simple terms to gain market approval. Compliance in the EU, US and Globally.

Created by: Martin Conneely
Academic

What Will I Learn?

• Define the roles and responsibilities of those involved in design control of a medical device
• Understand compliance of design control of a medical device.
• Understand the design control process.
• Compliance to ISO 13485, MDR, IVDR & CFR in the context of Design control.
• Learn how to plan and control the design and development of a medical device.
• Know what documentation is needed to record the design and control process.
• Understand the design control process via an example of a medical device which is a stent.
• Learn what the "Intended Purpose" is. How it relates to the design control process.
• Understand Risk management and how this impacts the design control process.
• Learn what the "Intended population", "Medical Indication" and claims. How these relate to the beginning of the design control process.
• Understand the User needs and where these user needs come from.
• How traceability is very important in the design control process. Input, output, verification and validation matrix will be an aid here.
• Understand what a design output is. Which will become the specifications of the medical device.
• Understand verification and the tests that are carried out to execute verification.
• Understand validation and what needs to be done to ensure the medical device functions as it was intended.
• Understand the review checks need to be executed during the design control process.
• How we transfer the design control process over to sustaining manufacturing.
• Learn how changes are controlled in a design control process.
• What documentation is required: Design History File (DHR), Device Master Record (DMR), Device History Record (DHR) and Technical Documentation.
• Really understand the "“Application of Design Controls to Waterfall Design Process” diagram, in very simple terms.

Requirements

• None
• You do not need any required skills to do this course. This course can be used for all levels, beginners, intermediate and higher levels. It explains design control in very simple terms.

Target audience

• All levels
• Design Engineers
• Production Managers
• Supervisor
• Technicians
• Manufacturing Engineers
• Process Engineers
• Quality Engineers
• Regulatory Affairs
• Quality Assurance
• Quality Control
• Process & Development Engineers
• Professional engaged in regulation especially in the medical device industry.
• Auditors
• Students who want to understand the medical device design control process.
• Entrepreneurs or small start up companies who want to develop a new medical device to gain market approval.