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Quick tips

Quick Tip: Software changes rapidly. Develop a framework for reassessing risks.
Many software changes are trivial and do not affect the user-interface. Consider developing a framework for re-assessing risks related to use-error…
Quick Tip: Use consensus standards database to identify state of the art
Identifying relevant state of the art for your medical device can be tricky. A good source is FDA's consensus standards database.
Quick Tip: Design your medical device to be robust to use conditions
Designing a medical device just for the "happy case" is not sufficient. Consider using the principles of robust design to for safe and effective…
Quick Tip: How MDs can collaborate to enhance medical device risk management
Clinicians with medical experience bring a unique perspective to safety risk management of medical devices that engineers lack. But clinicians also need…
Quick Tip: Watch out for misaligned incentives that compromise resilience
In today's ever changing world, risk management alone is not sufficient. We need to build resilient systems and products. Misaligned incentives at…
Quick Tip: Get your message across with clarity and precision
To communicate effectively with senior management, you need to learn about their communication preferences. Synthesize your key message in 2-3 bullet…
Quick Tip: Define the intended use early in the design process
Begin your design controls and risk management by first defining the intended use of your medical device. It is the first step in identifying applicable…
Quick Tip: Clock is ticking; start working on your QMSR transition plans
The Quality Management System Regulation (QMSR) goes into effect in February 2026. It is time to start working on your transition plans.
Quick Tip: Build deep competence in risk management to help your project team
Help your team by building competence in risk management whether it is your primary responsibility or not. Risk is inherent in every aspect of a project…
Quick Tip: PCCP is a great tool, use it with care
Predetermined Change Control Plan (PCCP) is a new regulatory scheme that can help you get to market faster. But it is not for every company or every…
Quick Tip: To be successful in a startup, don't try to do it all alone
Startups have a ton of energy and excitement, but not a whole lot of resources. Know the gaps for commercial success and don't try to do it all alone.
Quick Tip: Understand terminology first before going deep into regulations
Medical device regulations are complex and continuously evolving. Focus first on understanding key terminology and the big picture before going into…
© 2024 Naveen Agarwal, Ph.D.
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