Vulnerability Disclosure: Overview of Main Requirements
In today’s digitally connected healthcare landscape, the integration of medical devices with networked systems and electronic health records has revolutionized…
ISO 27001 Scope Template: A Practical Guideline
One of the most important document related to ISO 27001 is related to the definition of the scope of an…
Information Security Management System Policy
The Information Security Management System Policy is one of the ket document for an efficient management of information security and…
The PMCF (Post-Market Clinical Follow-Up) according to EU MDR 2017/745
The PMCF – Post Market Clinical Follow-up is part of active modalities to perform post-market surveillance activities and the requirements…
ISO 13485 and the FDA : The Future of Quality Management Systems
ISO 13485 and FDA: Harmonization with FDA QSR and insights on next version of ISO 13485 In this paragraph we…
