In the medical device industry, risk management goes beyond product development and manufacturing; it forms a vital aspect of the lifecycle of your product.
To ensure your organization brings a compliant product to market efficiently and safely, you need to successfully implement a risk management system.
Recognized by regulatory authorities in the US, Canada, Europe and more, BS EN ISO 14971 Medical devices. Application of risk management to medical devices provides internationally recognized methods to reduce risk for all stakeholders is the international standard helps medical device manufacturers establish, document, and maintain a systematic risk management process across all phases of the lifecycle of a medical device.
Adopting this standard early in the planning process will support you in ensuring that your medical device is compliant with EU Regulations and in bringing your medical device to the global market efficiently and safely.
For businesses looking to implement the medical device risk management best practices in BS EN ISO 14971 but want additional expert support, this Solution Pack can help.
This Solution Pack provides a comprehensive framework through which small and medium-sized medical device organizations can ensure the effective implementation of BS EN ISO 14971 and compliance for their medical devices.
Why should you use this Solution Pack?
For businesses, applying an effective risk management process to the manufacturing of medical devices can feel like a huge and costly challenge.
This Solution Pack has been specifically curated to include the standards and supplementary content required to support smaller and medium-sized enterprises implement the best practices provided in key medical device standard BS EN ISO 14971, without the need for hiring expensive consultants.
It provides your organization with all the necessary best practice guidance to assess your risks and consequently produce safe and effective medical devices. It covers how medical device manufacturers can establish, document, and maintain a systematic risk management process across all phases of the lifecycle of a medical device.
By choosing this Solution Pack, you are taking the first step in solving the technical challenge of adopting BS EN ISO 14971 and implementing an effective and compliant risk management system.
What’s included in this Solution Pack?
This Solution Pack provides all the necessary specifications, guidelines, and expert advice on how to implement standard BS EN ISO 14971 for the risk management of medical devices.
With this Solution Pack you’ll gain access to:
- Expert video interview. An interview with an expert on this solution pack and how to effectively apply BS EN ISO 14971
- An overview document of this Solution Pack. This introductory guide will explain how to use the contents of the pack to implement risk management best practices.
- The latest PDF version of standard BS EN ISO 14971 Medical devices. Application of risk management to medical devices.
- The latest PDF version of document PD CEN ISO/TR 24971 Medical devices. Guidance on the application of ISO 14971.
- The latest PDF version of expert commentary PD CEN ISO/TR 24971 ExComm Expert Commentary for PD CEN ISO/TR 24971:2020. Medical devices. Guidance on the application of ISO 14971
Who is this Solution Pack for?
This BSI Solution Pack is aimed at small and medium-sized medical device organizations who want support with implementing BS EN ISO 14971 Medical devices. Application of risk management to medical devices but don’t know where to start.
The curated content in this Solution Pack provides both the essential medical device risk management standard and supplementary material all in one place. It has never been easier to ensure to the safety of your medical devices by establishing an effective risk management system.