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| ISO 13485 Compliance | ||
ISO 13485 is a comprehensive management system for the design and manufacture of medical devices . This standard supplements the ISO 9001 quality management standard with additional requirements related to design controls, risk management, environmental controls, special processes (e.g. software validation), traceability, record retention and regulatory actions (such as vigilance), which are more critical for the medical device industry.
For companies that design, manufacture, distribute, install and service medical devices or raw material for the European and US markets and for companies providing services to the medical device market such as sterilization, cleaning, testing, etc., compliance with ISO 13485 is the first step in achieving compliance with US FDA and European regulatory requirements.
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MetricStream enables medical device manufacturers to ensure compliance with ISO 13485 through risk management, document control, compliance training, ongoing auditing, as well as recording and reporting of exception events and the resulting corrective actions.
ISO 13485 Resources
ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
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ISO 13485: Leading Towards Safer Medical Devices and Quality Management Systems
ISO 13485:2003 provides the description that maximizes the probability that a medical device organization will meet regulatory quality management system requirements worldwide, provide safe and effective medical devices, and meet customer requirements.
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News and Articles
Arrival of ISO 13485
ISO 13485:2003 is now upon us and compliance with this standard is mandatory in US & numerous countries where many US medical device manufacturers presently market their products. It is imperative to understand the scope and implementation process required for this Regulation. More so companies need to take action now before it is too late.
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Implementing ISO 13485
ISO 13485:2003 lists a number of the responsibilities of the organization in relation to the operation of the quality management system. It specifies that the organization shall identify the processes necessary for the system, determine the sequence and interaction of these processes, determine the criteria and methods for ensuring the effectiveness of the processes, ensure the availability of needed resources, m o n i t o r, measure and analyze the processes and implement actions necessary to achieve the planned results.
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