In the rapidly evolving medical device industry, ensuring the safety and efficacy of products is paramount. ISO 14971:2019 serves as the cornerstone for risk management in this sector, providing a robust framework to identify, evaluate, and mitigate risks throughout the product life cycle.
Key Highlights of ISO 14971:2019:
- Comprehensive Risk Assessment: the standard emphasizes a systematic approach to identifying hazards, estimating and evaluating associated risks and implementing effective control measures.
- Lifecycle integration: Risk Management is not a one-time task but an ongoing process that should be integrated into all phases of the medical device lifecycle, from design and development to production and post-market surveillance.
- Decision making based on data: by aligning Risk Management activities with empirical data and clinical evidence, manufacturers can make informed decisions that enhance product safety and compliance.
- Documentation and traceability: ISO 14971:2019 highlights the importance of detailed documentation, ensuring traceability and transparency in Risk Management processes.
- Stakeholder collaboration: The involvement of cross-functional teams, including engineering, clinical, regulatory and quality assurance, is critical to developing a holistic Risk Management strategy.
As we continue to push the boundaries of medical technology, adherence to ISO 14971:2019 ensures that patient safety remains at the forefront of our efforts. At Asphalion, we are committed to supporting the implementation of this standard in order to develop innovative and reliable medical solutions.
Let’s embrace this systematic approach to risk management and work together towards a safer future in healthcare innovation.
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Have a look at the complete flyer here: Risk Management ISO 14971
