Classifying the Undefined Devices under EU MDR

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Classifying the Undefined Devices under EU MDR

The medical devices and In Vitro Diagnostic devices (IVDs) under the European Union Medical Device Regulation (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (IVDR) 2017/746 are categorized into four (04) classes and twenty-two (22) rules (MDR)/ seven (07) rules (IVDR). Compared to the previous scope of the product in the Directives, the current regulation has expanded its scope. For instance, the EU MDR now covers contact lenses as well.  

Technical Writing for Medical Devices and Essential Tools to Know

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Technical Writing for Medical Devices and Essential Tools to Know

Technical writing is a profession that only seems easy and straightforward. It requires finer skills and involves the usage of various tools to create the right content and get the information that is apt and easy to understand. The challenge for technical writing begins with an in-depth understanding of the product or service, staying abreast of its functionalities, and knowing and understanding the target audience.

Designing User Guides for Software as a Medical Device (SaMD) - Overview

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Designing User Guides for Software as a Medical Device (SaMD) - Overview

Innovations in medical devices have increased manifold in recent years. This acceleration can be especially attributed to the vast development in cloud computing and the Internet of Things (IoT). Similarly, Software as a Medical Device (SaMD) has seen an increase in demand and remains a major contributor to the overall growth of the device industry.