ISO 14971 Risk Management Mastery (Medical Devices)
Master ISO14971 Risk Management for Medical Devices
A practical, case-based course for medical device companies.
This course shows you how to execute the risk management requirements and industry best-practices that meet ISO14971:2019 and align with ISO13485:2016.
Learn the following:
1. EXECUTE RISK MANAGEMENT WITH CONFIDENCE
Implement risk management over the device lifecycle
Create Risk Management Plans (RMP) and Risk Management Files (RMF)
Address risks associated with safety, device design and foreseeable misuse
Manage residual risks, overall device residue risk and review prior to product launch.
2. SET UP A BEST-PRACTICE RISK MANAGEMENT PROCESS
Set clear risk criteria for risks, residual risk and overall residual risk and document in your RMP.
Integrate ISO14971 risk management with ISO13485 design and development stages and stage-gates.
Align production and post-market surveillance tracking with residual risks for the device - know what to focus on.
3. APPLY THE RIGHT RISK TOOLS, THE RIGHT WAY
Understand the difference between PHA, FMEA/FMECA, FTA, HAZOP, and use-error analysis
Work through case studies for all stages of the risk management process
See examples of different tools with simple and complex device types
Avoid common misapplications that lead to audit findings
WHAT'S INSIDE?
COURSE MODULES
Foundations: Why Risk Management Matters - link between ISO14971 & ISO13485
The ISO14971 risk management process
Top Management responsibilities
Competence of risk teams
What is the Risk Management Plan
What is the Risk Management File
Risk analysis
Risks associated with intended use and foreseeable misuse
Safety risks of the device
Hazards and hazardous situations
Risk estimation
Risk evaluation
Risk controls
Residual risks
Benefit risk analysis and risk controls
Overall residual risk of the device
Risk management review
Production and Post-Production - Integration across the lifecycle
Risk management tools
IS THIS COURSE
FOR YOU OR YOUR TEAM?
You lead Quality, Operations, Design & Development, or R&D teams and need to strengthen your risk management understanding
Your team need to understand the ISO14971:2019 process
Your risk management documentation or process does not meet the ISO14971 requirements
You’re part of a medical device start-up and want to integrate risk management with design and development, right first time
You are preparing for regulatory inspection or submission of device files
If you answered yes to any of these, then this course is definitely for you and your team!
GET TO KNOW THE INSTRUCTOR
DR. KATHY WALSH
Principal Consultant & QSN Director
Kathy has over 24 years’ experience working in the pharmaceutical, medical device, and biotech industries, and many of their supporting areas such as distribution & wholesaling, secondary packaging, compounding, laboratory testing, R&D and clinical trials. She specialises in helping clients achieve their compliance and/or accreditation to regulatory requirements, particularly for:
Pharmaceuticals – Good Manufacturing Practices (GMPs) with various regulators
Medical devices – ISO13485 and ISO14971
Calibration and testing laboratories – ISO17025
Quality Management Systems (general) – ISO9001.
In addition to her scientific qualifications (PhD), Kathy is a qualified project manager, trainer, technical writer and Director of QSN.
WHY LEARN FROM KATHY?
See our reviews for training and consulting.
"Having worked with Kathy for many years, I can speak from first-hand experience of the exceptional quality of her work. Her honest, practical approach, and collaborative way of working is what makes her stand out from the rest. The improvements she identified and helped implement to the company's internal audit program resulted in an ISO13485 TGA A1 audit rating. Kathy's valuable service, knowledge and expertise is second to none. I highly recommend her and the QSN team to any company who wants a positive audit outcome."
Senior Quality & Regulatory Manager - GMP/Medical Devices
"Kathy did an extraordinary job leading our ISO17025 accreditation of our company in record time. Since the first day Kathy became an extension of our team and trained the staff not only to set up the quality systems but also so make sure they would own the systems that we were implementing. Kathy led the audit when the assessors were on site and coordinated responses post-audit, with very positive auditor feedback... I highly recommend Kathy to any company interested in the accreditation process, she will maximize the chances of success"
CEO
Biotech
The QSN team helped our company implement a QMS from scratch, and guided our team through accreditation in record time. Our business has been able to grow and access more clinical studies because of QSN’s expertise and Quality guidance.
CEO
Biotech/Clinical
"Our company relied heavily on Kathy and her team at QSN to build a GxP QMS from scratch, including supporting eQMS configuration, validation, SOP detail and process development, and supported our TGA audit... I would highly recommend Kathy and her team at QSN to any pharma start-up or company."
Quality Manager
GMP Pharma
"I personally wanted to say thanks to you and the rest of the QSN team for all the QA and QMS support as we have now received notification that we have passed our ISO 13485 Stage 2 Audit."
QA Manager
Medical Devices
"The masterclass... Documentation Transformation Pathway – Every Industry, Every Business!... was absolutely brilliant, useful, insightful and reminding basic principles in making simpler, easy to understand documents in almost all functions and areas.
QA Manager
GMP Pharma
"QSN helped with our audit readiness - their willingness to provide support and share their knowledge and experience with the team was the best thing about their service."
QA Manager
GMP Pharma
"The best thing about QSN is their knowledge, experience and they're just a great lot of people to work with. They know what they're doing yet they can be humble and always professional on their approach on things!
Project Manager
Medtech
"QSN have a can-do attitude with positive mindset and proactive approach to problem solving. This was a great asset in helping us to focus on solutions and accomplish the tasks at hand."
Operations Manager
Medtech
Excellent videos, clear, concise and very informative. Kathy is a great source of knowledge and her help and advice is always invaluable for us.
Quality Systems Manager
Medtech
Clear structure, right level of details, up to date information, useful for any medicine manufacturers/sponsors. Catering for all customer needs with the text and video.
Quality Manager
Medtech
The course is providing a very clear and sequential training deck which would aid in learning for new trainees and trainees who are refreshing their knowledge.
Quality Manager
GMP Pharma
Very well structured and presented nicely (as expected from a professional writer)
Training Attendee
Kathy is a very pleasant and good communicator with efficient style!
Training Attendee
This was a very clear and informative, to the point, webinar.
Training Attendee
FREQUENTLY ASKED QUESTIONS
Ready to explore QSN Academy? Start by checking out our FAQs!
Why aren't prices displayed for our courses?
Our courses are not cookie cutter products. They are intended to be flexible to meet our client’s needs for training or upskilling personnel. Courses can be delivered in a variety of ways and with the option for add-on premium face to face training. Our courses are primarily aimed at B2B teams and companies, but can also be purchased by individuals. And we can also offer combinations of courses for specific client needs. All of these moving parts are assessed on a case-by-case basis for each client during the scheduled call. Consequently, prices may vary depending on client needs.
Are you committing to buying the course if you schedule a call?
No. The scheduled call is only to establish your specific training needs and what would work best for your circumstances. As part of the discussion on the call, you may choose to proceed with requesting an invoice for the recommended training solution, or not. You may also choose to not proceed with buying the training solution once an invoice is sent to you. Please just let us know that you no longer wish to proceed with the purchase.
What payment methods are used?
We will send B2B clients an invoice for payment of the training solution agreed in the scheduled call. Individuals wanting to buy an online course for their own use will be sent a link where they can pay using a credit card.
When do you get access to the course?
Online access to courses is available once payment is made.
How long do you get access to online courses?
Access to online courses is for 6 months.
What materials/software do you need?
We recommend using the Google Chrome browser for accessing online content.
Can you share your login details?
No, you must not share login details with someone else. QSN reserves all rights to our content.
Can you access the course on mobile devices or tablets?
Yes. Log in to the training platform using the registration link sent to you using Google Chrome on your phone or tablet.
When do you complete premium face-to-face training sessions?
We will organize a mutually agreed date with you for delivering premium training sessions once payment is made.
Can you use training materials to train others?
Yes. Downloadable files attached to online courses or used during premium face-to-face sessions may be used by you for in-house/internal training or developing your own training materials as part of your QMS. Video content must not be downloaded or copied. Courses, training materials and files must not be shared with others outside of your company. QSN reserves all rights to our content.
Is there a certificate of completion?
Yes. You will receive an email when you successfully complete the online course assessment. That email will contain a link to download your certificate of completion. If you do not receive an email, please check your junk folder or reach out to [email protected].
Is there any instructor support or course support available?
Yes. Some online courses are activated to allow you to post questions to the instructor from online lessons. You may also email us at [email protected].
Can I get a refund if I’m not satisfied with the course?
Online courses are non-refundable if you or your team have been given access to a course. Face to face premium training costs may be refunded within 10 days of purchase. However, any customizations to premium training content requested by you will not be refunded.
Can I access the course materials after completing the course?
Yes. You will have continued access to the course materials for 6 months even after completing the course.
