Excellence Beyond Compliance

10

Fully Incorporating Risk Management

Risk management is a subject that has received a lot of attention in recent years. Risk management is important to each business in terms of managing all risks related to the business.^1,2 Indeed, there is an international standard for risk management: ISO 31000:2009.³ Principles of risk management are critical for patient safety in healthcare organizations.⁴

Concern for patient safety drives medical device companies to focus particularly on product and process risk management. The key standard is ISO 14971, recently updated with annexes to provide additional information beyond the text (which remains identical to the 2007 publication) with regard to European requirements.⁵ A guidance for application ...