IVDR & Risk Management
We all know that Risk Management is an important part of a medical device’s quality management system. It also plays an important role in establishing objective evidence for the conformity with the General Safety and Performance Requirements (GSPR) of the EU 2017/746 (IVDR) IVD Medical Device Regulation. When carrying out a risk assessment, the state-of-the-art… Read more
Performance Evaluation Under EU 2017/746/ IVDR
Performance evaluation (PE) is an important part of design validation and technical documentation required to place an in vitro diagnostic device (IVD) on the EU market. Article 56 of the EU 2017/746 In Vitro Diagnostics Regulation (IVDR) requires manufacturers to prepare a performance evaluation report to demonstrate the safety and performance according to the manufacturer’s… Read more
Medical Device Software Life Cycle Management
The increased validation requirements of MDR (EU 2017/745) bring new challenges to the manufacturers of devices utilizing software and standalone software which are considered as medical device in line with the Article 2 of the MDR. EN/IEC 62304:2006/A1:2015 is a basis standard which defines requirements for Medical Device Software Life Cycle Processes. In addition … Read more
MDR Clinical Evaluation Requirements
MDR Clinical Evaluation Requirements including clinical investigation are defined on Chapter VI, Annex XIV and Annex XV respectively. As you know, to CE Mark a medical device under MDR, the importance of obtaining clinical data and evaluation is extremely important. Especially for implantable and Class III devices manufacturers shall implement a very carefully designed PMCF… Read more
PMCF, PMS and PSUR Requirements
PMCF (Post Market Clinical Follow-Up) is maybe one of the most challenging new MDR (EU 2017/745) requirements. As many of you know, MDR has increased requirements for clinical evaluation and market surveillance. The importance of the clinical data shows its effects for post market surveillance as a more detailed PMCF process. Of course this shall… Read more
US FDA 510 K Submission – How to prepare a 510 K File?
Food and Drug Administration (FDA) is the legal authority to establish rules and regulation for the use of medical devices within the United States. According to Food, Drug, and Cosmetic Act products falling within the scope of medical devices, shall be registered in FDA database. In that sense, FDA 510 K clearance is required for… Read more