How to be compliant with ISO 27001?
Tips for implementation of the ISMS ISO 27001 is an international standard providing requirement for the implementation of the information…
ISO 62366 and Usability Requirements for Medical Device
ISO 62366 plays a fundamental role in the design process for medical device as it explains the requirements related to…
Management Review
General Requirements It is important to demonstrate that top management reviews the suitability, adequacy and effectiveness of the organization’s quality…
Easy Guideline to GXP Compliance
GXP requirements became more and more important in the last years. In this post, we provide an easy guideline to…
IEC 62304:2006 – Medical Device Software
IEC 62304:2006 is an internationally recognised medical device standard which provides a framework for the development, testing and maintenance of…
Corrective and Preventive Actions (CAPA)
There is no doubt that CAPA (Corrective and Preventive Actions) is one of the most important process of any Quality…
The Role of Economic Operators within the EU MDR 2017/745
Who are Economic Operators according to EU MDR? The term Economic Operators is explained in article 2 of EU MDR…
Post-Market Surveillance for EU MDR
New Requirements for Post-market Surveillance The EU MDR 2017/745 and IVDR 2017/746 provides a big revolution for post-market surveillance, with…
ISO 10993-1 : Biocompatibility Evaluation for Medical Devices
Biocompatibility evaluation according to ISO 10993-1 and the related biological risk assessment is one of the most important validation activities…
ISO 20416:2020 – Post-Market Surveillance for Medical Device.
ISO 20416 post market surveillance
