Medical device manufacturing is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied.
Patient safety greatly depends on the quality and consistency of medical products, and ensuring effectiveness, control, and maintenance of a quality management system is critical to customers, stakeholders, patients and users, and regulatory agencies
To ensure your organization brings a compliant product to market efficiently and safely, you need to successfully implement a quality management system.
BS EN ISO 13485 Medical devices. Quality management systems. Requirements for regulatory purposes gives regulatory requirements for medical device quality management systems. It provides the basis for ensuring consistent design, development, production, installation, and delivery of products that are safe for their intended purpose. It also harmonizes global requirements and is recognized by regulators in many jurisdictions around the world.
Adopting this standard provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. It helps you to bring your medical device to the global market efficiently and safely.
For businesses looking to implement the medical device quality management best practices in BS EN ISO 13485 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 13485 and compliance for their medical devices.
Why should you use this Solution Pack?
For businesses, applying an effective quality 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 13485, without the need for hiring expensive consultants.
It provides your organization with all the necessary best practice guidance to assess your quality and consequently produce safe and effective medical devices. It covers how medical device manufacturers can ensure ensuring consistent design, development, production, and delivery of products that are safe for their intended purpose.
By choosing this Solution Pack, you are taking the first step in solving the technical challenge of adopting BS EN ISO 13485 and implementing an effective and compliant quality 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 13485 for the quality 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 13485
- An overview document of this Solution Pack. This introductory document will explain what is in the pack and how you can access the expert video interview.
- The latest PDF version of standard BS EN ISO 13485 Medical devices. Quality management systems. Requirements for regulatory purposes
- The latest PDF version of expert commentary BS EN ISO 13485 ExComm Expert Commentary for BS ISO 13485 devices. Guidance on the application of ISO 13485
Who is this Solution Pack for?
This BSI Solution Pack is aimed at small and medium-sized organizations who want support with implementing BS EN ISO 13485 Medical devices. Quality management systems. Requirements for regulatory purposes but don’t know where to start.
The curated content in this Solution Pack provides both the essential medical device quality 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 quality management system.
This pack is designed to enable you to implement a quality management system for medical devices. This is one of several solutions BSI offers within this area.
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Enhance your skills with BSI Academy training courses and qualifications
Better understand regulatory requirements and gain a stronger understanding of ISO 13485 with BSI Academy’s range of Medical Devices training courses. Grow your understanding of key medical device regulations including IVDR, MDR and MDSAP which can help ensure your products are safe and compliant for use.