General information about ISO 14001

Environmental management by obtaining ISO 14001 certification

The purpose of adopting this system is to preserve the profitability of production while reducing the level of negative impact on the atmosphere, hydrosphere, soil, and to minimize the amount of waste. Companies can confirm the adoption of and compliance with environmental management by obtaining ISO 14001 certification. Any company or business activity affects the…

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General information about ISO 14001

General information about ISO 14001

Environmental Management System standard provides not only the environmental result, but also the result of financial benefits for the organization, whose activities are built on the principles of ISO 14001. ISO 14001 ISO 14001 (Environmental Management System, EMS) is a tool that allows you to control the environmental impact of a firm, reducing it to…

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ISO 13485 Medical Devices

ISO 13485 Medical Devices

Safety in quality is very important in the medical devices space. Regulatory requirements are becoming increasingly stringent throughout the product lifecycle, with a focus being placed on competence, requirements, and design validation activities. In addition, there is a larger expectation for organizations to not only demonstrate product compliance, but adherence to their own quality management…

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IVDR IVDD Changes

Proposed changes to IVDR transitional arrangements.

The Covid pandemic has seen some significant disruption in the release and adaptation of new (and revised) regulatory requirements globally. None mores so than the release of MDR and IVDR. We thought we would share some proposed amendments to the IVDR (Regulation EU 2017/746) around transitional arrangements moving from IVDD (Directive 98/79/EC). The intent is…

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Manufacturing, TIG Welding, ISO9001, RSVA

How a QMS Can Meet Your RVSA Obligations

There are many inherent benefits of being certified to a Quality Management System (QMS). It shows regulators and customers alike that your business takes quality seriously and you have the tool kit to understand requirements, control your processes, deal with issues, and continually improve your products and services to exceed their expectations. Our blog post...
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Importing from China – Some real considerations

The current economy makes turning to China for goods worthwhile. Even with manufacturing and custom parts, China organisations are more than willing to accept low MOQ’s to increase trade. All these things make it appealing for smaller businesses (and large ones alike) to turn to our Chinese friends for services and goods. However, there are…

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Make use of Usability. How to get it right… and wrong.

In the medical device world, Usability Engineering (IEC62366 The application of Usability Engineering or its 60601 counterpart IEC60601-1-6) is a required tool within the validation of a medical device. Regardless of if it’s, software, active, or IDV, Usability engineering helps us understand how the device (or system) react within a real-world application. It draws from the…

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