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

Implant Card Requirements of MDR

Implant card (IC) is one of the new requirements of the MDR – EU 2017/745. The requirements specified in Article 18 will bring new challenges to the daily life of the implantable device manufacturers. The guidance MDCG 2019-8 includes useful hints, which will help the manufacturers during design of an IC. Before diving into details … Read more

ISO 13485 Quality Management System

ISO 13485:2016 is a quality management standard for medical devices. This standard provides a basis for the quality management system in parallel to the EU MDR and other international regulatory changes which occurred since the second revision of the standard. On the other hand, this 2016 revision brought requirements closer to the US FDA expectations, … Read more