Ensuring regulatory compliance when CE marking a device as sterile requires a good level of technical knowledge and the involvement of your manufacturing and QA / RA departments, as well as your sterilisation provider.
As Europe’s leading supplier of outsourced sterilisation services, Isotron is uniquely positioned to provide an expert’s insight into sterilisation techniques and our experiences gained by applying the ISO 11137 standards to a whole host of devices ranging in size and complexity.
Isotron’s upcoming education day event, entitled ‘How to Ensure Your Device is Sterile: An Insight into Microbiological Validation and Compliance’, will provide a valuable overview and enhanced understanding of your sterilisation obligations to your customers.
The education day will cover the following:
- The features and benefits of irradiation technologies for sterilisation
- The microbiological validation regulations for irradiated products
- A practical insight into applying these standards to ensure product compliance
- Guidance on dealing with failures and large, complex devices
- An insight into future standard developments
The fee for the event is £205 (excluding VAT). To confirm your attendance at this event please email education@isotron.com or call +44 8456 88 99 77.