Miscellaneous

For any medical device, there must be sufficient clinical evidence to corroborate compliance with relevant essential requirements for safety and performance. One of the most crucial components for a thorough and complete Clinical Evaluation [...]

There are only a handful of explicit things that you MUST do for Post Market Surveillance under the European Medical Device Regulation (MDR 2017/745); however, there are many things you SHOULD be doing to continuously [...]

Breaking Down EU MDR Implementation for Class 1 Medical Devices   Breaking Down EU MDR Implementation for Class 1 Medical Devices Following the one-year delay in the MDR Date of Application, the Class I [...]

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 [...]

Want to know what the most commonly criticized document in an MDR submission is? Your clinical literature review. Reviewing the literature is essential to the clinical evaluation process for medical devices. The clinical evaluation [...]

A literature review is a formal collection of scientific studies published in peer-reviewed journals or conference proceedings that are relevant to the safety evaluation of a medical device product.   Literature reviews are essential [...]

The term market surveillance covers the activities carried out by national regulatory authorities to ensure the safety and efficiency of products placed on the market. In these activities, the national regulatory authorities put measures [...]

EU MDR is undoubtedly a fantastic way of upgrading the medical device market quality, but the process is anything but easy. With the slow but steady transfer of MDD to MDR, various aspects of requirements [...]

The term summary of safety and clinical performance has recently sent the medical manufacturing world into a buzz. The new MDCG 2019 9 update published by the EU comes with some new rules for the [...]

A literature search is a systematic search through existing data in an organized way to determine an extensive range of quality references to a specific subject.   Literature searches serve many functions for a medical [...]

The short answer is, yes, it can be. MDR compliance may not have been expensive in the past, but as the regulations are changing, so is the cost to follow them. The new rules [...]

The Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Regulation 2017/746 (IVDR) are two sides of the same regulatory coin in almost all aspects: both regulations seek to set up a regulatory system [...]