While an extension has been issued on the ISO13485 requirements for licencing, the 3 year period should be used constructively to ensure compliance by the deadline. Understanding the requirements of ISO 13485 is often seen as daunting and many don’t know where to start. At our next Regulatory Forum, Shiroma Bennimahadeo from Lloyd’s Register will assist in understanding ISO13485.
Description
While an extension has been issued on the ISO13485 requirements for licencing, the 3 year period should be used constructively to ensure compliance by the deadline. Understanding the requirements of ISO 13485 is often seen as daunting and many don’t know where to start. At our next Regulatory Forum, Shiroma Bennimahadeo from Lloyd’s Register will:
- Explain what ISO 13485
- Outline what needs to be in place before considering certification
- Unpack the planning and preparation required for audits
- Offer advice on the best ways to engage notified bodies
- Overview the costs associated with ISO 13485
- Share some tips for quick wins and overcoming challenges/setbacks
Who should attend?
Regulatory personnel and those who want to gain a greater understanding of medical technology regulations
Programme
09:00 Welcome and Formalities
09:05 Understanding ISO 13485
Shiroma Bennimahadeo, Lloyd’s Register
11:00 Close
