dear All
I am working on risk management plan according to 2019 edition
and need help to understand the requirement clearly
1-the scope of the planned risk management activities, identifying and describing the medical device and the life cycle phases for which each element of the plan is applicable
* for this point i highlight the product description /intended purpose and highlight the product life cycle (design /product realization / post-production )
2- assignment of responsibilities and authorities;
* for this point we provide a list of the team member,role and duties and of course cross-reference their competence
3-requirements for review of risk management activities;
* indeed i don't clearly understand this point, (however in old edition its written how and when these review activities did) ,
4-criteria for risk acceptability, based on the manufacturer’s policy for determining acceptable
* this point clear for me to determine the Accebptiblity level
5-a method to evaluate the overall residual risk, and criteria for acceptability of the overall residual
* in this point i don't understand if we need to create another acceptability level for residual risk ???
Also if based on the estimated Probability & severity the risk is acceptable so result considers a residual risk ??
6-activities for verification of the implementation and effectiveness of risk control measures;
* as per my understanding verification of implementation may through
- Compliance to applicable standards and guidelines
- Clinical evaluation data
- Comparison with predicate devices
- Instruction for use of predicate devices
- Suppliers information
- Bench-Top tests.
- Inspection
- Validation activities and Expert opinion
- 7-activities related to collection and review of relevant production and post-production information.for
- for this point below information could be used
- Data from production and post market surveillance include the following:
- Customer complaint
- Customer feedback
- Clinical evaluation data
- Nonconformities
- so can any one help to execute good plan