Systems and Procedure Packs according to Article 22 of EU MDR
The requirements pertaining to system and procedure packs can be found in Article 22 of EU MDR 2017/745. This article…
ISO 14644 : Requirements for Cleanrooms
The ISO 14644 family of standards serves as a comprehensive guide for establishing and maintaining cleanroom environments, especially in the…
Trend Reporting According to EU MDR and IVDR
In this comprehensive article, we will delve into the requirements for Trend Reporting as outlined in Article 88 of the…
IEC 82304-1 and its Application for Stand-Alone Software
IEC 82304, in conjunction with IEC 62304, plays a critical role in the realm of software-based medical devices. While these…
Medical Devices containing Ancillary Medicinal Substances
Ancillary medicinal substances are medicinal products that are incorporated within a medical device, with the device being the primary driver…
ISO 13485 Audit
ISO 13485 audit is the methodology through which certification body performs the assessment of a quality system of an organization…
EU Reference Laboratories according to IVDR
As we have already mentioned in other articles, the in-vitro diagnostic sector is undergoing to significant changes due to introduction…
ISO 15189: QMS for Medical Laboratories
ISO 15189 is an international standard to be followed for the implementation and maintenance of quality management system of medical…
eCRF and Clinical Trials
An electronic case report form (eCRF) serves as a fundamental tool in the collection of data for clinical studies and…
Companion Diagnostic: Overview of the Regulation
According to the definition provided by European Medicine Agency (EMA), a companion diagnostic is an in-vitro diagnostic test that supports…
