Medical device companies MUST have established risk management processes that comply with ISO 14971. And it doesn’t matter if you are developing medical devices in the U.S., EU, Canada, and so on. ISO ...

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 ...

Once the risk team has been assembled, the crucial process of identifying risks must commence. The output of the risk ...

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 ...

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 ...

Kayla Missman specializes in making complicated topics more approachable. She has eight years of experience in journalism, editing and marketing, allowing her to dive into interesting topics and ...

Today’s fast-moving world demands that risk management be an imperative more than ever before. From shifting global economic futures and environmental challenges to increased development in new ...

Kristina Zucchi is an investment analyst and financial writer with 15+ years of experience managing portfolios and conducting equity research. Andy Smith is a Certified Financial Planner (CFP®), ...

Dan Moskowitz is a financial writer who has 4+ years of experience creating content for the online reading market. Chip Stapleton is a Series 7 and Series 66 license holder, CFA Level 1 exam holder, ...