Design & Development, Medical Device

Design Considerations for Electrical Safety in Medical Devices

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.

Medical Device, Risk management

Video | Risk Management in Medical Devices

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.

Medical Device, Risk management

ISO 14971 Let’s Go! The Ultimate Guide to Risk Management in 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.

Design & Development

“Your Design Input Specification is important beyond regulatory compliance”

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”