Searching the FDA 510k Database for Regulatory Strategy: What Medical Device Manufacturers Need to Know? The FDA 510k database is an important tool for medical device manufacturers. Understanding how to use it can help you stay compliant with FDA regulations and strategically plan your regulatory strategy in the United States. Perform FDA 510k database search…
Everything You Need To Know About Medical Device Coordination Group (MDCG) The Medical Device Coordination Group (MDCG) is a regulatory body of health and industry experts with the goal to improve medical device coordination, ensuring the safe and effective use of medical devices in Europe. The group is mainly known for publishing MDCG guidance starting…
Understanding the Differences Between MDD vs MDR: The European Regulation There are many regulations in place that govern how medical device manufacturers can produce and supply their products. The EU has a few different regulatory requirements for medical devices. In Europe, there is the MDD (Medical Devices Directive) as well as MDR (Medical Device Regulation).…
How to Comply with the New ISO 13485 2016 Standard? ISO 13485 2016 (or EN ISO 13485 2016 for Europe) is the latest standard for medical devices. It was published in July 2016, and it has a lot of changes from ISO 13485:2003. ISO 13485 2016 includes new requirements for quality management systems and documentation…
EU MDR harmonized standards first set released The manufacturer must justify and document the design steps of his device. He must verify compliance with the requirements of Annex I to the European Medical Device Regulation 2017/745 dedicated to general safety and performance requirements. EU MDR harmonized standards and reference requirements can be used for that…
What is the new EU MDR? Everything you need to know The European Union (EU) Medical Device Regulation is the latest step in regulating medical devices in the European Union and has been developed to strengthen the monitoring of the medical devices on the market and their manufacturers. The EU MDR has been made effective…
What is UDI Unique Device Identification or UDI is a system that provides harmonized positive, globally and single identification of medical devices through usage and distribution. The system has two parts, which are UDI-PI and UDI-DI. The UDI-DI is the device identifier that has the power to identify a particular device within your portfolio, which…
ISO 14971 RISK MANAGEMENT FOR MEDICAL DEVICES Let’s review the background of ISO 14971. As a medical device manufacturer, the first thing you need to do is to make sure that your devices do what they are supposed to do. Then, you need to make sure that they meet the set regulations and standards for…
What is the IVDR? There has actually been an EU Directive (98/79/EC) controlling in vitro diagnostic medical devices (IVDs). Nonetheless, troubles emerged with the analysis and also application of that Directive, especially that it provided only reduced degrees of examination for possibly ‘high risk’ devices therefore EU IVDR regulation was enacted. IVDR meaning is:…
Keeping Your Medical Devices Safe with the Latest Cybersecurity Solutions In the ever-changing world of medical devices, one thing is for sure: the FDA and other regulators have been taking a much closer look at what needs to be done in order to keep patients safe in this connected world. In fact, the FDA’s guidance…