Medical Device Industry - Standards
Adopting industry standards, such as those developed by the ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission), enables companies in the medical device industry to improve product quality, environmental friendliness, safety, reliability, efficiency and interchangeability. Many industry defined standards have also been recognized by the Global Harmonization Task Force and regional regulatory bodies, meaning that conforming to these standards provides the additional benefit of aiding an organization in demonstrating compliance with government regulation. However, compliance to standards without an automated solution such as PTC Integrity can also slow development, increase costs, and restrict innovation.
Three standards in particular are critical to the realization of medical device products and medical device products with software.
- ISO 14971 - Application of Risk to Medical Devices - ISO 14971:2007 provides a framework for managing risk in order to reduce problem reports and customer complaints, minimize the probability or severity of harm to end users, and lower product maintenance costs. The PTC Integrity solution for Medical Device companies provides a configurable Risk Management platform that leverages ISO 14971 risk management methodologies through the implementation of Hazard and Risk Analysis documentation, coupled with risk management and risk control processes.
- ISO 13485 - Quality Management Systems - Medical Device manufacturers apply this standard to improve quality in the design and development as well as production, customer care and installation of medical devices. PTC Integrity provides a process-based, documented Quality Management System (QMS) that fulfills key requirements of this standard, and as ISO 13485 shares a lot of commonality with the cGMP (current Good Manufacturing Practice) principles, PTC Integrity reduces the cost and time required to comply with both FDA and EU quality systems regulation for medical devices.
- IEC 62304 - Software Life Cycle Processes - IEC 62304 demands that software development for medical devices includes requirements traceability, independent code reviews, module/integration testing, system testing and risk management appropriate to the level of risk associated with the software system. PTC Integrity provides a single platform for traceability management, configuration management, requirements management, code reviews, unit/module testing, integration testing, test protocol management as well as the classification of risk and safety for medical device software components. By using PTC Integrity to satisfy IEC 62304 organizations can visualize software components, their safety classifications and trace software components to all levels of related process, including risk management and testing. This traceability and software decomposition will enable an organization to achieve a solid understanding of the state of each software component and the direct impact to the overall medical device safety, reliability and quality.