punyam academy
92 posts
Feb 21, 2024
4:10 AM
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A Matter of Life and Safety:
The primary reason boils down to patient protection. Each medical device, from simple bandages to complex implants, has the potential to impact lives. By adhering to the stringent requirements of ISO 13485, manufacturers demonstrate a commitment to:
- Identifying, hazards and risks: The standard promotes a proactive approach, requiring systematic identification and control of potential hazards throughout the entire device lifecycle, from design and development to manufacturing and post-market surveillance.
- Implementing robust quality control processes: Defined procedures, rigorous inspections, and meticulous documentation ensure consistent quality at every stage, minimizing errors and defects.
- Maintaining traceability and transparency: A comprehensive record-keeping system allows for clear tracking of materials, components, and devices, facilitating efficient incident investigation and recall management, should the need arise.
Why Prioritizing ISO 13485 Requirements is Crucial for Medical Device Manufacturers?
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