Breakfast seminar - The role of Risk Management in 62304

Oct 19, 2010
Stockholm, Sweden

Don’t miss this opportunity to take part in Synergus breakfast seminar on Risk Management for Medical Device SW! The harmonization of standard IEC/ISO 62304 and changes in MDD are setting a new expectation level of what Medical Device manufacturers need to do regarding software validation.
A fundamental regulatory requirement related to Medical Device SW is implementing a SW Risk Management process according to ISO 14971.

Software is also different compared to electronics and mechanics, and needs to be treated according to that fact.

Many manufacturers are implementing processes for SW validation, and are striving to find an optimal approach delivering safe products as a productive organization. When correctly implemented, SW Risk Management can optimize the amount of documentation needed and enable an effective Verification and Validation strategy.

Synergus Senior Consultant Robert Ginsberg will guide you through this topic in a 45 minutes seminar followed by 15 minutes of Q&A.

Time & Date: