Getting stuck is a normal part of a product developer's life, here are 9 ways to fix that!
As technology improves, this presents new complexities and hazards to the system. Therefore, medical electrical equipment must be compliant with applicable standards to protect individuals within medical facilities from potential electrical harm.
What is Risk Management? Here is a beautiful presentation to help you understand what Risk Management in Medical Devices looks like in compliance with ISO 14971; the standard for the application of risk management to medical devices.
Risk Management is defined as the “systematic application of management policies, procedures and practices to the tasks of analyzing evaluating controlling, and monitoring risk” Basically, risk management means the right people doing the right activities at the right time to prevent harm.
An insufficient or incomplete design input specification (DIS) can lead to a host of problems and create a big mess. A design input specification is a design control requirement for medical devices seeking regulatory approval. According to the FDA, your DIS must be testable, measurable, unambiguous, and traceable. Ambiguity leads to poor design inputs. … Continue reading “Your Design Input Specification is important beyond regulatory compliance”
A design input specification (DIS) plays a critical role in any product design process. The product DIS contains all the characteristics of a device that are used as a basis for product design. The level of detail that your design inputs cover can be the deciding factor that makes or breaks a smooth run to… Continue reading KICKSTART YOUR DIS: 6 Approaches to Generate Design Inputs
You’re sick and tired of being sick and tired. You gave it all you can… with all that you have… but you’re still stuck. Frustrating! In the last entry, we left to get some energy back and some clarity. Now let’s get you out!
Getting stuck doesn’t make you a failure—it makes you human. Accept that you are stuck and look for clues to answer this question: How did you get here?
“Why me?” —you may think. Overwhelmed and stressed out, you feel like the odds are stacked against you. You may feel anger. You may feel scared. Worst of all, you feel some embarrassment. You are bogged down.