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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SoftComply offers Free Apps to get More Ventilators and Test Kits for COVID-19 to Market Faster

Medical equipment at the Columbus Covid-2 Hospital, in Rome, on March 16, 2020 from The Globe and Mail With the lack of medical equipment in light of the rapid spread of COVID-19 and the hospitalization of infected people (1), SoftComply offers their support to medical device companies. Medical device companies are currently working non-stop to […]

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Six Must-Have Atlassian Apps for MedTech Companies

Which tools should I pick from the Atlassian stack? Jira? Jira Software? Jira Core? And then there is a marketplace full of apps that sit on Jira and Confluence. Can I pick one from there or do I need apps at all? These and many similar questions are asked by almost all new Atlassian users […]

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What is MDR Up-Classification and its Extension

For a number of Medical Device companies, Christmas arrived earlier in 2019. On the 17th December 2019, the second Corrigendum to the Medical Device Regulations was formally approved. This has interesting consequences for some Class I devices, that until now would have had to go through the full rigour of the MDR as of the […]

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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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