Miscellaneous

Implementing the MDR or Medical Device Regulation will bring significant changes to the process of Clinical Evaluation and subsequent post-market compliance requirements. This, of course, is a significant concern for medical device manufacturers in the EU. [...]

The regulatory landscape in Europe is changing. In 2021, the new medical device regulation was implemented; in 2022, it was time for the in vitro diagnostic regulation. While the medical device regulation did not [...]

Even for experienced medical writers and regulatory staff, writing a compliant clinical evaluation report (CER) for medical devices can be tricky. Regulations and guidelines change, as does the attitude of the notified bodies. A [...]

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 [...]

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 elucidate [...]

All MedTech companies face increased post-market surveillance (PMS) requirements under the EU MDR and IVDR. A PMS plan will incorporate a Post-Market Clinical Follow-up (PMCF) plan or justification for why it is unnecessary.   [...]

The Medical Device Regulation (MDR) has been a regulatory framework since 2017. The MDR is designed to ensure that medical devices are safe, effective, and high-quality. While the EU had given time for the [...]

A systematic literature review is one of the most important stages of the CER process, but it's also time-consuming and labor-intensive.   Literature review software tools make the process a little easier by streamlining the [...]

Most of us are familiar with clinical evaluations for medical devices. Easy peasy. But when it comes to the equivalent for in vitro diagnostic medical devices, the performance evaluation, most of us are a [...]

In the fast-paced world of healthcare, there are always concerns regarding any new medical device. The concern about cybersecurity in medical devices or, in plainer words, getting hacked or getting your data out on [...]

Understanding the Landscape of Global Medical Device Regulations The global landscape of medical device regulations is as diverse as it is complex. Navigating through these regulations requires a deep understanding of the nuances that [...]

Medical writing is hard. It's tricky, technical, and sometimes exceptionally tedious. Suppose you chose literature reviews as your niche or form part of the regulatory staff selected for clinical evaluations. In that case, I'm sure [...]