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1. ISO MEDICAL DEVICES RISK MANAGEMENT UPDATE
2. ISO MEDICAL DEVICES RISK MANAGEMENT SOFTWARE
3. ISO MEDICAL DEVICES RISK MANAGEMENT ISO

Jama Connect offers risk management item templates to capture important information about the risk analysis process, including a description of the device, intended use and the scope of the analysis. Jama Connect helps teams satisfy Clause 5 by defining device-specific hazards and capturing risk probability and severity. Each hazardous situation and its potential consequences must be evaluated.

ISO MEDICAL DEVICES RISK MANAGEMENT ISO

Clause 5: Risk AnalysisĬlause 5 of ISO 14971 requires that medical device developers identify potential hazards and hazardous situations. It’s a component of the Risk Management File, which contains all the outputs for risk. The Risk Management Plan is the record of a planned process for risk management: who does what and when, how risks are scored, etc. It requires the formation of a Risk Management Plan throughout the development lifecycle. Risk Management PlanĬlause 4 of ISO 14971 concerns how risk is organized and administered for your product line. Jama Connect guides compliance with Clauses 4 through 7 of ISO 14971, which cover how risk should be managed throughout the product development process. That’s where Jama Connect comes in: It allows teams to easily connect risks, requirements and testing in one system where requirements and test results stay live in real time. Many medical device companies continue to depend on Excel to capture risk data, but Excel simply can’t provide the end-to-end traceability necessary for satisfying ISO 14971.

For medical device developers, risks are a core principle of product development and should be tied together in one powerful platform. Risk management is an inextricable part of the medical device development process.

Managing Risks & Requirements for ISO 14971 The standard was recently updated in 2019 providing more guidance on risk management and adding more detailed requirements. Jama Connect™ offers a straightforward approach to managing risk according to ISO 14971 in one platform. ISO 14971 is an international standard that sees risk management as a product lifecycle process encompassing development, production and post-production stages. In this post, we’ll outline the main clauses of ISO 14971 and explain how Jama can help medical device developers build better, safer products that satisfy ISO 14971. In our experience working with more than 200 medical device developers, we’ve realized how important it is to create best practices for risk management under ISO 14971, the FDA’s mandatory standard for risk assessment throughout the product development lifecycle.

ISO MEDICAL DEVICES RISK MANAGEMENT SOFTWARE

This announcement comes on the heels of significant enhancements to Greenlight Guru’s change management workflows, the launch of Digital Design Reviews, and the company’s fifth consecutive quarter as a G2 Crowd market leader in the quality management software category.įor more information about Greenlight Guru’s risk management capabilities, visit week, Jama Software launched Jama Connect for Medical Device Development, which helps teams speed time-to-market without compromising quality or compliance.

ISO MEDICAL DEVICES RISK MANAGEMENT UPDATE

Greenlight Guru’s timely platform update to help medical device companies comply with these changing regulatory standards is proof that they eliminate the burden of allocating internal resources to update the design and quality processes for customers, allowing them to stay current with evolving industry regulations and compliance requirements. “The update to our platform not only conforms to the new standard but represents our continued dedication to being the best quality management system for medical device companies.” “This iteration of the ISO 14971 standard is the first update in nearly 13 years, and offers much-needed clarifications to reflect current best practices,” says Jon Speer, founder and vice president of QA/RA at Greenlight Guru. It serves to define better key terminology, residual risk identification, and personnel competence. Put into effect in December 2019, ISO 14971:2019 is the latest update to the application of risk management for medical devices. ISO 14971 is the predominant standard for risk management in the medical device industry, of which compliance is required in the United States, Canada, and the European Union.