Successful risk management is essential to the design and development of safe and effective medical devices. Unfortunately, it is too often viewed by manufacturers as an isolated activity that must be ...

Designed to address the needs of users and patients. Designed to meet inputs and requirements. Proven to meet applicable standards. Meets performance criteria. Realize Design Controls and Risk ...

Interconnectedness of medical devices can be a huge benefit to society. For instance, the MRI machine used to scan a patient’s back can instantly transmit the images to the practitioner in their ...

These definitions as written out by AAMI (The Association for the Advancement of Medical Instrumentation) offer clarity, helping designers recognize and address these risks effectively in product ...

The design and construction of capital projects can be extremely complex. Uncertainty and risk add to this complexity and, as a result, many projects experience significant cost overruns and schedule ...

ITRA covers Sections 2 and 5 of the Security Standard for the Solutions Life Cycle Management (SLCM) process. You can find a link to the Security Standard: Solutions Life Cycle Management process in ...

Discover essential risk assessment methods, including qualitative and quantitative analyses, to make informed investment ...

Risk management is the process of identifying, analyzing, and mitigating uncertainties and threats that can harm your company or organization. No business venture or organizational action can ...

If most midsize companies have a formal risk management process, why did so many fail even in pre-pandemic years? The problem is that risk heat maps — many companies’ primary tool for assessing risk — ...