Risk Management is an integral part of any Quality System, yet companies are struggling to keep up with regulatory updates and the impact on their QMS.
Significant changes in the regulatory climate have shifted to risk-based processes, providing a greater emphasis on the Risk Management files for medical related products.
ISO 14971:2019 was issued to harmonize those concepts across multiple regulatory bodies and incorporates some significant changes in the existing risk management landscape.
The processes described in ISO 14971 assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
Join internationally esteemed regulatory experts Audrey Prosser and Rebecca Waterbury for an interactive session covering the key changes to ISO 14971 as they give you practical approaches for implementation of the new standard for both new products and legacy products.
Learn about the key updates to ISO 14971:2019 and hear insights from other companies implementing the revised standard. Explore best practices for updating risk documentation and staying compliant with international standards.
How ISO 14971:2019 applies to your company
Key changes from prior versions of the ISO 14971:2019 Standard
Key timing for implementation of updates across different global requirements
Tips for creating the Risk Management file for new products
Tips for updating legacy Risk Management files to current standards
Effectively evaluating Risk Management files during design change
Effectively evaluating Risk Management files and incorporation of Post-Market Surveillance information
Medical device executives
Quality Professionals and Quality Management
R&D Engineers and Management
Persons creating and/or updating Design Control processes
Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient.
Visit our homepage to learn more.
Exemplar Compliance is a global consulting firm specializing in Quality, Regulatory Compliance, Automated Quality Solutions, and Logistics. Experienced staff work with large and small companies to implement strategies for FDA remediation, product approval, product launch, quality system implementation, quality audits, and international logistics. The defining characteristic of their service is the implementation of practical, compliant, quality solutions. At Exemplar we believe that “Quality Matters,” and it is the only strategy for successful product approval and commercialization. We believe in educating our clients on every project and creating strong, knowledgeable teams. Exemplar Compliance works with companies in all phases of development and commercialization and across product types such as traditional pharmaceuticals, biologics, dietary supplements, medical devices, IVD, and combination products.
Visit their website to learn more.