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Medical Device Risk Management

ENSURE THE SAFETY OF YOUR PRODUCT THROUGH ISO-14971 COMPLIANT RISK MANAGEMENT FILES AND PROCEDURES

Don’t wait for risk management to become a documentation exercise at the end of your project; our team is ready to improve your design process by identifying risks early and letting our risk management process inform your designs to create safer, more effective products.

We have experience preparing FDA- and MDR-compliant submissions using ISO-14971 standards and guidance as well as experience working with both SaMD and hardware medical device products. Our expertise in writing risk management files extends to making them accessible and easy to process for any required audience including product development teams, post-market change teams, auditors, and post market surveillance and complaint teams.

Risk Management Procedures
Establish effective risk management procedures within your QMS (Quality Management System)


Our risk management team is ready to help document

>> How risk fits into your development process
>> How the Risk Management File is be organized into different deliverables
>> How the risk management files will be managed within your QMS
>> How the risk process overlaps with post-market and complaints procedures

Our team is deeply experienced completing ISO-14971, FDA and MDR compliant risk files as well as integrating risk management with the medical device design controls requirements (21 CFR 820 & ISO-13485).
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Risk Management File
Create comprehensive Risk Management files from start to finish.

From Risk Management planning to final Risk Management reports, our RM team is ready to help your product team:

>> Fit risk management into your existing design and development process
>> Organize the Risk File into different deliverables
>> Plan deliverables, reviews and approvals
>>Perform preliminary hazard analysis
>> Create robust and realistic risk criteria
>> Identify potential clinical harms
>> Assess cybersecurity, manufacturing, and use-related risks
>>Identify risk control measures (RCMs)
>> Verify the implementation and effectiveness of RCMs
>> Identify residual risks and communicating them to the end user
>> Analyze the Benefit-Risk
How Risk and Human Factors Work Together
With expertise in both Risk Management and Human Factors/ usability, Sage Research + Design is uniquely positioned to help navigate these processes (ISO-14971 and IEC 62366), where they intersect and how to fully satisfy both within your quality management system.

Our team is equipped to:

>> Identify the overlap between the risk management file and the usability file
>> Integrate use errors into risk assessments
>> Utilize usability validations for risk mitigation
>> Ensure the usability AND safety of your designs




What our Clients Say
netflix
SKYE LEE
Netflix, Inc.
Sr. UX Manager

Shannon is an amazing usability and overall user experience consultant. She is extremely professional, detail oriented, and a great team player. Whether you are interested in qualitative or quantitative data, Shannon can gauge the project and your needs and make sure you obtain all the information you need along with a tactical way to move forward on making your product a success.

ebay
ELISSA DARNELL
ebay, inc.
Director of User Experience

It was a wonderful experience working with Shannon. She took on a challenging project for us with an uncertain outcome. Her research expertise resulted in a final product that far exceeded my expectations. The creativity and customer focus Shannon brought to my project was impressive! I look forward to working with her again.

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MARY GRIBBONS
Indeed
UX Research Director

I feel like there are two layers of results which Sage provides us. The first layer provides the answers to our original problem at hand, and they are VERY actionable. The second layer goes up and beyond our expectations. Sage packages up research themes so nicely that we’re able to apply the research to further projects down the line and build up our general knowledge base.

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FRANCINE WALKER
The Florida Bar
COMMUNICATIONS DIRECTOR

Your comprehensive site review and professional analysis, usability testing, navigation card sort, and design style guide set our redesign efforts on a clear course that helped us improve site usability. The detailed reports are full of examples, explanations and visual aides that continue to be a valuable reference as we continue our efforts to improve The Florida Bar website. We are happy to serve as a reference and to recommend Sage Research & Design as an excellent resource for improving usability.

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TIM ENWALL
Tendril, Inc.
Founder, CEO, President & COO, CIO

I hired Shannon when I was with Access Graphics and again for Tendril Networks. We found Shannon’s input very helpful and appreciated that she found a way to work within our tight budget. You’ll see upon reviewing her credentials that it’d be pretty hard to find a more qualified and experienced user interface expert. I highly recommend Shannon.

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KIMBERLY OSLOB
Userzoom, Inc.
VP of UX Client Services

When a project comes up that requires UX consultancy work, Shannon is the first person I think of and will call. She is, without a doubt, an asset to any company and will help bring your design to the next level with her stellar research and design skills. I would highly recommend Shannon for any project that requires an excellent User Experience as a result.

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