Risk Assessment in Medical Device Design: Unleash the Potential of Medical Device Design
Boost Compliance and Patient Safety: Discover the Power of Risk Assessment!
Instructor :
John Misock
Webinar ID:
6431
Date: DEC 13, 2024 (FRI)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
What you will learn
- Design Risk Assessment, Systems-Approach
- DMADV, Risk Significance, Likelihood of Occurrence
- Stakeholder Needs, Design Risk Best Practices
- ISO 14971, ISO 13485, ALARP vs. ALAP
- Intended Use & User Needs, Risk Assessment…
- Design Risk Assessment, Systems-Approach
- DMADV, Risk Significance, Likelihood of Occurrence
- Stakeholder Needs, Design Risk Best Practices
- ISO 14971, ISO 13485, ALARP vs. ALAP
- Intended Use & User Needs, Risk Assessment
- Verification, Validation, Risk Acceptability Matrix
- Risk Control “Phase”, Risk Control Measures
- Device Master Record, Design review, Waterfall diagram
Course Description
Design Risk Assessment is a “risk identification and mitigation planning” framework practitioners, and teams use during the design process.
The critical differentiator between design risk assessment and other risk assessment frameworks is that design risk assessment uses a systems-level approach to analyze risk, meaning the team evaluates all risks associated with the design process and not solely the project outcomes or outputs.
Much like the FMEA tool, design risk assessment requires a systematic assessment of the process and products; however, design risk assessment is done with a holistic view of the organization.
Design risk assessment is to a Define, Measure, Analyze, Design, Verify ( DMADV) project as FMEA is to a Define, Measure, Analyze, Improve, and Control (DMAIC) project.
Risk assessment is a valuable addition to the design process because identifying risk decreases uncertainty (a key factor in effective change management) and increases the chances that the design will meet the objectives.
Risk assessment is a loose term encompassing risk identification, assessment, and mitigation.
Risk assessment’s core is fear of the unknown or a sense of dread that comes from uncertainty. Any risk assessment activity is to identify possible risks and ways to prevent or minimize those risks before they happen.
Design projects have higher levels of uncertainty because of the lack of precedent for the process or product.
From an FDA compliance perspective, design risk assessment is the basis for product life-cycle analysis which the FDA now expects firms to consider the process in a continuous feedback loop to ensure patient safety effectiveness of the device.
In this interactive webinar, John Misock, with over 40 years of experience working with complex FDA and EPA regulations, will share best approaches to achieve compliance.
Join Now!
Design Risk Assessment is a “risk identification and mitigation planning” framework practitioners, and teams use during the design process.
The critical differentiator between design risk assessment and other risk assessment frameworks is that design risk assessment uses a systems-level approach to analyze risk, meaning the team evaluates all risks associated with the design process and not solely the project outcomes or outputs.
Much like the FMEA tool, design risk assessment requires a systematic assessment of the process and products; however, design risk assessment is done with a holistic view of the organization.
Design risk assessment is to a Define, Measure, Analyze, Design, Verify ( DMADV) project as FMEA is to a Define, Measure, Analyze, Improve, and Control (DMAIC) project.
Risk assessment is a valuable addition to the design process because identifying risk decreases uncertainty (a key factor in effective change management) and increases the chances that the design will meet the objectives.
Risk assessment is a loose term encompassing risk identification, assessment, and mitigation.
Risk assessment’s core is fear of the unknown or a sense of dread that comes from uncertainty. Any risk assessment activity is to identify possible risks and ways to prevent or minimize those risks before they happen.
Design projects have higher levels of uncertainty because of the lack of precedent for the process or product.
From an FDA compliance perspective, design risk assessment is the basis for product life-cycle analysis which the FDA now expects firms to consider the process in a continuous feedback loop to ensure patient safety effectiveness of the device.
In this interactive webinar, John Misock, with over 40 years of experience working with complex FDA and EPA regulations, will share best approaches to achieve compliance.
Join Now!
Why you should attend
If your team is developing a new process or product, you will want to perform a design assessment.
According to the FDA:
- Approximately 30% of medical device recalls occur due to design-related issues?
- 10% of medical devices on the market have serious safety issue.
Similar to traditional risk assessments, design risk assessments prepare design teams to identify and manage risk throughout and upon completion of the design project.
In addition, design risk assessment provides a design team with a framework to perform a risk assessment.
Uncertainty will undermine progress.
- Without a robust design risk assessment, project teams may be derailed by over-engineering solutions to minimize risk. Instead, if the team commits to revisiting the risk assessment, the designers can focus on meeting customer objectives rather than mitigating adverse outcomes.
Reduce waste and reengineering costs.
- Teams must invest in robust risk assessment to identify and mitigate as many risks as possible before prototyping and verifying that the product or process meets the customer’s needs and requirements.
Join Mr. Misock to learn how to effectively identify possible risks and ways to prevent or minimize those risks before they happen.
Enroll Now!
If your team is developing a new process or product, you will want to perform a design assessment.
According to the FDA:
- Approximately 30% of medical device recalls occur due to design-related issues?
- 10% of medical devices on the market have serious safety issue.
Similar to traditional risk assessments, design risk assessments prepare design teams to identify and manage risk throughout and upon completion of the design project.
In addition, design risk assessment provides a design team with a framework to perform a risk assessment.
Uncertainty will undermine progress.
- Without a robust design risk assessment, project teams may be derailed by over-engineering solutions to minimize risk. Instead, if the team commits to revisiting the risk assessment, the designers can focus on meeting customer objectives rather than mitigating adverse outcomes.
Reduce waste and reengineering costs.
- Teams must invest in robust risk assessment to identify and mitigate as many risks as possible before prototyping and verifying that the product or process meets the customer’s needs and requirements.
Join Mr. Misock to learn how to effectively identify possible risks and ways to prevent or minimize those risks before they happen.
Enroll Now!
Areas Covered
- Design risk assessment
- Systems-approach
- DMADV
- Risk Significance
- Likelihood of occurrence
- Stakeholder needs
- Design risk best practices
- ISO 14971
- ISO 13485
- Intended use & user needs
- Risk assessment
- Verification
- Validation
- Risk Acceptability Matrix
- ALARP vs. ALAP
- Risk Control “Phase”
- Risk Control Measures
- Device Master Record
- Design review
- Waterfall diagram
BONUS:
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Design risk assessment
- Systems-approach
- DMADV
- Risk Significance
- Likelihood of occurrence
- Stakeholder needs
- Design risk best practices
- ISO 14971
- ISO 13485
- Intended use & user needs
- Risk assessment
- Verification
- Validation
- Risk Acceptability Matrix
- ALARP vs. ALAP
- Risk Control “Phase”
- Risk Control Measures
- Device Master Record
- Design review
- Waterfall diagram
BONUS:
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
Who is this course for
Managers in the medical device industry, such as:
- Director of Quality
- Director of Regulatory Affairs
- Director of Engineering
- Vice President of Product Development
Engineers who are involved in the design, development, or manufacturing of medical devices, such as:
- Medical Device Engineers
- Quality Engineers
- Validation Engineers
- R&D Engineers
Regulatory Affairs Professionals who are responsible for ensuring that medical devices meet regulatory requirements, such as:
- Regulatory Affairs Managers
- Regulatory Affairs Specialists
- Quality Assurance Specialists
Other professionals who are involved in the safety and effectiveness of medical devices, such as:
- Clinical Engineers
- Medical Writers
- Risk Managers
Managers in the medical device industry, such as:
- Director of Quality
- Director of Regulatory Affairs
- Director of Engineering
- Vice President of Product Development
Engineers who are involved in the design, development, or manufacturing of medical devices, such as:
- Medical Device Engineers
- Quality Engineers
- Validation Engineers
- R&D Engineers
Regulatory Affairs Professionals who are responsible for ensuring that medical devices meet regulatory requirements, such as:
- Regulatory Affairs Managers
- Regulatory Affairs Specialists
- Quality Assurance Specialists
Other professionals who are involved in the safety and effectiveness of medical devices, such as:
- Clinical Engineers
- Medical Writers
- Risk Managers
Instructor Profile
John Misock is a Senior Regulatory Consultant with Ceutical Laboratories, Inc. Flower Mound, Texas. John brings over 40 years of experience working with complex FDA and EPA regulations to help industry manufacture safe and effective products.
Previously John worked at FDA leading outbreak investigations and serving as a SME in compliance cases. He also served a global regulatory compliance role with Estee Lauder Companies prior to joining FDA.
After graduate school and before joining Estee Lauder John served as Deputy Commissioner and Food and Drug Director with the Wyoming Department of Agriculture. John is a recognized expert in microbiology and GMP in FDA regulated products.
Expertise
- Regulatory compliance
- QMS
- NDA/ANDA
- IND
- 501k
- International regulatory compliance, ICH, MDR
