samd

SAMD

“Software as a Medical Device (SaMD)” – A New Trend in Healthcare Software as a Medical Device (SaMD) is an innovative trend in healthcare. SaMD software bridges the gap between medical devices and information technology, using software to improve patient care. It has been growing steadily over the past few years, but only recently have…

Medical Device Cybersecurity

medical device cybersecurity

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…

what is udi

What is UDI

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 13485 2016

iso 13485 2016

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…

MDCG

MDCG

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…

MDD vs MDR

MDD vs MDR

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).…

Medical Device Post Market Surveillance in Canada

Health Canada collects post-market information from a wide variety of sources after products are approved for sale in the Canadian market, then evaluates information to come up with appropriate safety measures involving medical devices. Signal detection and assessment Health Canada continuously receives and evaluates Medical Devices Incident Reports and Post-Market Adverse Reaction Reports. Through the…

What is the new EU MDR

EU MDR

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…

EU MDR standards

EU MDR harmonized standards

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…

510k

510k

FDA 510k: Everything you need to know about preparing a premarket submission for medical devices A 501k is a device classification that allows manufacturers to sell their products without first obtaining approval from the FDA, but only if they meet specific criteria. That is, an FDA 510k submission is the technical documentation required by the…