Paper-based Quality Management Systems are now (almost) a thing of the past (it’s sooo 20th century…). But in some cases, printing records and documents from the eDMS is necessary, or at least exporting them to PDF. The requirements for paper documents are the same as digital documents. But, unlike electronic formats, physical misplacement or loss […]
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 […]
What is a Technical File?
The Technical File is a dossier required for marketing a medical device in Europe (a.k.a. receiving the CE mark). For Class III devices, this is called Design Dossier and has a few additional requirements. The Technical File is intended to show compliance with the applicable MDDs ( Medical Device Directives, the EU regulatory framework for […]