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Design Controls and Design Quality
I help medical device companies navigate the design control process with safety and your customers in mind. I have years of experience in both systems engineering and design quality, so I can help you with everything from design plans and risk management to requirements traceability and V&V plans. I'll also make sure that your sample size rationale is valid, your tests are executed properly, and your results are interpreted correctly. I'll even write your reports for you!
Software Management
Are you looking to transition to Agile? Is your backlog a mess? Does your team need help interpreting or implementing ISO 62304, GDPR, or the FDA's guidance document on cyber security?
I’ve been tackling these questions since 2008. I can help you get your medical device software development and management processes in order, so you can focus on bringing your products to market.
Risk Management
I have extensive experience in leading all sizes of medical device risk management projects, from writing compliant SOPs tailored to your business to remediating an entire client portfolio to managing post-market surveillance and risk updates for launched products. I will work with you to develop a risk management portfolio that meets your specific needs and ensures the safety of your products.
QMS Development
Start-ups and small medical device companies often need help developing a quality management system (QMS). I provide customized QMS development services that are tailored to the specific needs of each client. I don't use templates, so I can ensure that the SOPs I deliver are the right fit for your company.
I also have experience implementing and validating electronic quality management systems (EQMS). If you're interested in switching to an EQMS, I can help you choose the right platform and implement it in a way that meets your specific needs.
Human Factors and Usability
Incorporating human factors and usability into new product design helps not only with compliance but also with creating more robust, intuitive, and appreciated devices. I have designed, executed, and reported on a number of studies to meet this goal.
My human factors system offering includes:
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User research: I will work with you to understand your users' needs and goals.
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Usability testing: I will test your product with users to identify usability issues.
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Design recommendations: I will provide you with recommendations for improving the usability of your product.
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Training: I can provide training to your team on human factors and usability principles.
I am passionate about helping companies create products that are safe, effective, and easy to use.
Project/Program Management
Is your medical device project team struggling to keep track of all the deliverables? Do you feel like you're constantly putting out fires and nothing is ever getting done on time? If so, I can help.
I'm a medical device program manager with over 16 years of experience in the industry. I've helped teams large and small manage projects on time and on budget. I know how to juggle multiple tasks and keep everyone on track. I'll work with you to develop a project plan that meets your specific needs and then I'll execute it flawlessly.
Trusted by Companies and Entrepreneurs
Throughout the Country
Organized and Efficient
"The project was behind and the deadline was firm. Brittany came on board and quickly came up to speed. Despite the sheer amount of documentation that needed to be completed, Brittany got it done and effectively communicated her progress throughout."
Sr. Engineering Management
TerumoBCT
Flexible and Committed
"I don't know where we would be without Brittany on the team."
Quality Manager- Risk Management
Easy to Work With
It has been a pleasure working with you, and I'm grateful for your contributions to the team. Beyond that, you are a very nice and bright person, and overall I enjoyed your company and how well you fit in with our team.
R&D Leader
ConMed