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Risk Management

Risk Management

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.

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...
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