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Risk Management with qmsWrapper

for achieving and maintaining ISO 13485:2016, CE Mark or U.S.QSR (21CFR 820) for 510(K) Compliance Success

In our fast paced world, the risks we have to take and manage, in order to continue to grow and to develop, evolve quickly. Effectively managed risks help companies
achieve their goals.

Products that are developed following quality standards, have improved the quality of life for thousands of people. We believe that the ideal of improving the quality of life is the very premise of product risk management.

Risk Management for Medical Devices as defined by ISO 14971

Improve your chances of a successful, if not perfect, project.

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qmsWrapper is designed for companies who have a mission to constantly deliver quality in their products.

qmsWrapper Risk Management is a powerful, but user-friendly tool, that makes risk & compliance management easy for everyone.

Our software solution improves the chances of a successful, if not a perfect project plan for startups, mature organizations, IT Quality teams, PMOs, Governance and especially medical device companies who are facing unique challenges with Design Controls and Risk Management.

It can be integrated into the design process from the get-go, then revisited at every phase.

The simplicity of the platform is increasing the effectiveness, so you can spend your limited time and energy tracking risks and planning mitigations instead of managing a tool.

qmsWrapper has an integrated approach to managing risk across an organization.
 It’s flexible so it can be appropriate and proportionate to the complexity and type of
organization involved. 

Risk Management on qmsWrapper

Risks can be inherent at every product phase and every product generation from product planning, through the production, to post-production phase, throughout the entire product’s lifecycle. RM needs to be available for access at any time -so you don’t have to reinvent the wheel each time.

All the necessary information, like the hazardous situation at risk identification phase, the hazard categories are on a single interface, graphically mapped out for a simple overview. 

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"some level of failure is inevitable, but a use of a smart risk management system can help to mitigate the frequency and severity of failures."

The different type of risks and the actions to be taken can be incredibly diverse.

The software is based on ISO 14971 guidance and combined with a flexible system where you can create your own Risk processes, including approval workflows, and define your own risk varieties and action plans. 

It can be appropriate and proportionate to the complexity and type of organization involved.

Provides a step by step sequence of task with appropriate explanations and cautions that makes possible for risk or quality managers even with little experience to appropriately perform their risk related tasks.

 

Your risk controls will have a direct impact on your design outputs, as well as your verification and/or validation activities.

If you’re ready to get serious about your risk management and product development efforts, qmsWrapper is your solution. 


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