Risk Management - ISO 14971

Market Access for your medical device and in vitro diagnostic 

Risk Management

Need support getting your risk management file ISO 14971 compliant?

Medical device companies must have established a risk management process that complies with ISO 14971. ISO 14971 is formally recognized as the risk management standard by regulatory authorities in the US, Europe, Canada, Australia, and more. ISO 14971 improves your organization's ability to reduce uncertainty, and your ability to achieve the critical objective of ensuring device safety and effectiveness.

ISO 14971 helps your company with a systematic process to manage the risks associated with the use of a medical device and In vitro diagnostic. To maximize the effectiveness of your risk management system, ISO 14971 should be part of your quality management system (QMS) as required by ISO 13485. 

Our experts understand what it takes to manage process interactions to produce the desired outcome: patient safety. Qserve's team of RA/QA consultants can help you understand and comply with the requirements of ISO 14971:23019  in global markets in an efficient, cost-effective way. 

Our Risk Management Services

Planning - Define the scope of risk management activities and integration with your QMS.
Documentation - Identify gaps and opportunities to improvement.
Risk Analysis - Helping manufacturers focus on and address risk management activities to effectively analyze the risk associated with their devices.
Post Market Surveillance (PMS) - Making Risk Management complete and ensuring PMS feeds into Risk Managament.

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