Designing for Sterilization – Regulatory Requirements – 1 day course

Course Outline

This course is designed for people who are involved in the design, development, production and quality control of sterile medical devices.

The sterilization of medical devices is a key area in the development of new healthcare products. Therefore the need to understand and compare the available technologies as well consider key influencing factor such as polymers, packaging and regulatory requirements is essential for any manufacturer of sterile devices.

The relationship between manufacturers and sterilization provides is an important element on the supply chain and should be well established in order to bring devices to market.

Getting the design wrong can have catastrophic consequences in terms of project costs, time to market and customer complaints. This course will provide you with a valuable insight into the factors that should be considered in relation to designing a sterile medical device.

Topics covered include

• General introduction to the theory & technology of radiation (gamma & beam) and ethylene oxide (EtO) sterilization
• Effect of there technologies on polymers
• Understanding how electronics can be incorporated into sterile medical devices
• Working with your sterilization provider to improve service to your customers
• Regulatory requirements when labeling medical device as sterile

Outcomes

• Understanding of the technologies involved in medical device sterilization
• Key challenges and considerations for device design
• The design pathway of a typical sterile medical device
• Importance of sterilization
• The impact of the sterilization process on the device
• The various regulatory requirements for each of the main sterilization processes
• Risk management of the design and it’s sterilization process

Venue

• Holiday Inn, Birmingham, UK
• Close to Birmingham International Airport & International train station (with free shuttle bus)
• 1 minute from junction 6 of the M42