Applied ISO14971 Medical Device Risk Management

Applied ISO14971 Medical Device Risk Management, available at $129.99, has an average rating of 4.37, with 21 lectures, 4 quizzes, based on 776 reviews, and has 2151 subscribers.

You will learn about Understand the ISO14971 medical device risk management requirements and sequence Understand the roles and responsibilities of a risk management team Construct a risk management plan Apply the FMEA and 5×5 matrix in risk analysis Understand the relationship between risk evaluation, risk control and medical device testing Iterate the risk management process to evaluate residual risks Use risk/benefit analysis to assess residual risks Apply the Fault-Tree and Event Tree Analysis to evaluate residual risks Understand the importance of the risk management file Understand the type of post-production information required Dealing with unforeseeable risks in risk evaluation This course is ideal for individuals who are Medical device startups or Members of the product development team or Members of the senior management team or Regulatory Affairs Professional or Regulatory Affairs Professionals or Quality Assurance Professionals or Development Engineers or Operations/Production Managers or Technical Sales and Marketing Professionals It is particularly useful for Medical device startups or Members of the product development team or Members of the senior management team or Regulatory Affairs Professional or Regulatory Affairs Professionals or Quality Assurance Professionals or Development Engineers or Operations/Production Managers or Technical Sales and Marketing Professionals.

Enroll now: Applied ISO14971 Medical Device Risk Management

Summary

Title: Applied ISO14971 Medical Device Risk Management

Price: $129.99

Average Rating: 4.37

Number of Lectures: 21

Number of Quizzes: 4

Number of Published Lectures: 18

Number of Published Quizzes: 4

Number of Curriculum Items: 25

Number of Published Curriculum Objects: 22

Original Price: $129.99

Quality Status: approved

Status: Live

What You Will Learn

• Understand the ISO14971 medical device risk management requirements and sequence
• Understand the roles and responsibilities of a risk management team
• Construct a risk management plan
• Apply the FMEA and 5×5 matrix in risk analysis
• Understand the relationship between risk evaluation, risk control and medical device testing
• Iterate the risk management process to evaluate residual risks
• Use risk/benefit analysis to assess residual risks
• Apply the Fault-Tree and Event Tree Analysis to evaluate residual risks
• Understand the importance of the risk management file
• Understand the type of post-production information required
• Dealing with unforeseeable risks in risk evaluation

Who Should Attend

• Medical device startups
• Members of the product development team
• Members of the senior management team
• Regulatory Affairs Professional
• Regulatory Affairs Professionals
• Quality Assurance Professionals
• Development Engineers
• Operations/Production Managers
• Technical Sales and Marketing Professionals

Target Audiences

• Medical device startups
• Members of the product development team
• Members of the senior management team
• Regulatory Affairs Professional
• Regulatory Affairs Professionals
• Quality Assurance Professionals
• Development Engineers
• Operations/Production Managers
• Technical Sales and Marketing Professionals