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Risk Management

Risk Management

6 Traits of Effective Risk Management in the Life Sciences Industry

Risk Management

June 26th, 2024

10 min read

Risk is inherent across all areas of the life sciences industry. From pharmaceuticals to biotechnology and medical devices, there’s a high level of risk in the development of products across each of these sectors. An effective risk management process helps life sciences organizations identify potential issues before they occur, so they can put preventive measures...

The Essential Guide to ISO 14971

Medical Device Manufacturing

March 25th, 2022

8 min read

The International Organization for Standardization created ISO 14971 to assist medtech manufacturers in developing processes for evaluating, monitoring and controlling the risk that their products could cause harm to patients, operators, or other individuals. ISO 14971:2019 is the third and most recent edition of the standard.
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5 Necessary Steps for Building a Risk Assessment Framework

Best Practices

January 14th, 2022

7 min read

The life science sector is one of the country’s most lucrative industries. It’s currently worth $7.7 billion and is expected to attain a CAGR of 7.8% between 2021, and 2028.  But with huge rewards come huge risks, and the life science industries are abundant with them. From global volatility, intellectual property theft, to strict and...