Miscellaneous

Medical writers make up much of the medical device regulatory industry. In fact, they are one of the largest contributors behind the thousands of devices that get conformity approval each year. However, good medical [...]

A quality management system is a huge part of producing medical devices. Whether you like the process or not, a well-designed and well-executed QMS is your security man who controls what goes in and [...]

The medical device development process is not a one-step operation. Instead, it is a multi-phase process requiring meticulous planning and implementation so that you get a safe and effective device at the end of [...]

Move over, Dr House, there's a new diagnostician in town, and it's not human! Thanks to the power of AI, medical devices are becoming smarter than ever, analyzing data faster than ever and creating regulatory [...]

The medical device industry has been changing bit by bit every day, and one of the significant changes is the addition of technology to medical devices. While medical testing devices, scans, and robotic surgical [...]

Literature reviews are an essential part of the clinical evaluation process for medical devices. The clinical evaluation report assesses a medical device's benefit-risk profile to ensure its continued safety, efficiency, and compliance. Most regulatory [...]

The new clinical trial regulations that are in place right now will streamline applications and increase transparency.   The current clinical trials regulatory framework for the European Union (EU) has entered into effect this [...]

    For manufacturers, clinical trials or at least the protocol are already planned and set to go for up to 2023. However, a new development in the clinical trials regulation means what you [...]

Clinical trials are a crucial piece of launching a medical device. Publishing the data you have gathered regarding the safety and effectiveness of your product is the first step of proving its quality attributes. [...]

The EU MDR emphasizes field safety corrective actions to correct non-conformances of the distributed product, but since these principles are used throughout the quality system, they are not limited to the distributed product alone. Preventive [...]

Healthcare is undergoing a paradigm shift as cutting-edge technology makes its way into medical devices, tele-health, and digital health solutions. Most modern medical devices are manufactured with integrated software and software in general has become [...]

Introduction to Software as a Medical Device in MDR The MDCG's Guidance document defines the criteria for software qualification falling within the scope of the EU MDR and IVDR.   This article seeks to [...]