How to Use Confluence Pages as Templates

Summary SoftComply has released a new Confluence Server macro within the SoftComply eQMS app that allows the user to use any Confluence page as a template, copying it automatically into the existing space at a click of a button. Features include the addition of prefixes, suffixes, timestamp and more. This bypasses the use of Confluence […]

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How to Turn Confluence into a Compliant Document Management System for Medical Devices

WHY CONFLUENCE? Most medical device companies need to have at least a compliant quality management system in place, not to mention the quality records that will always need to be generated during the lifecycle of the device. With your software development team using Jira, it is natural that your organisation would like to have everything […]

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Comparison of SoftComply eQMS & MediCompli Solution

What is a Quality Management System? You probably know that Medical Device companies are required to have a Quality System in place, in order to be able to market their products in most countries in the world. This Quality System, or Quality Management System – QMS, is a collation of Procedures, documents, templates and records […]

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MDR: Equivalence in Clinical Evaluations

Demonstrating equivalence to an existing, marketed medical device has always been a practical way to show that a new device is safe and effective, and lengthy clinical trials are not required. Now, the “new” EU MDR introduce a new variation in the concept of “equivalence” for medical devices. Annex XIV, Part A, Clinical Evaluation lists […]

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Afraid of the new MDRs?

By Matteo Gubellini, Chief Regulatory Officer at SoftComply Who’s afraid of the MDRs and the new approach to risk management in the EU? Well, everyone! The new and scary regulations for medical devices in the European Union will be made effective towards the end of this month. Driven by the necessity of updating an old […]

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New Medical Devices Regulation & Risk Management

The revised Medical Devices Regulation (MDR) will change the regulatory environment of medical devices in Europe to a more stringent one. Compared to the MDD, the MDR promotes a life-cycle approach similar to what the US FDA and many international standards advocate. MDR highlights the importance of medical device risk management. Although risk management has […]

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