Relationship between FDA & ISO 13485

The relationship between the FDA and ISO 13485 goes back a long time. The ISO standard has been in the list of General Consensus Standards since the dawn of times, but there has never been a full alignment between 21 CFR 820 (QSR) and ISO 13485. It’s like these couples that have been together forever, […]

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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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Risk Management – part of a Quality Management System?

Risk Management is a key and mandatory part of a medical device development process. Unfortunately, Risk Management is often treated as merely an exercise required to achieve compliance rather than a tool to achieve an optimum design and to ensure the safety of the medical device. Let’s see how to get the best out of […]

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What is Document Control? Automated vs Paper-Based?

Although this process can be extremely complicated and interlaced in large corporations, the requirements for Document Control are actually quite simple. Let’s give a look at them: ISO 13485:2016 – it’s all in two paragraphs, §4.2.4 and §4.2.5: (a) Documents must be approved, i.e. have signatures (electronic or handwritten); (b) If reviewed or modified, they […]

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SoftComply eQMS for Medical Device Companies has arrived!

SoftComply is pleased to announce SoftComply eQMS, the first Atlassian add-on addressing the needs of life-science, medtech and pharma companies has arrived. SoftComply eQMS: • fast-tracks the implementation of a compliant Quality Management System for medical device companies; • is comprehensively focussed on the EU and US based markets, and helps users fulfil their requirements […]

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