EU MDR

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 [...]

The literature review is a critical part of any clinical evaluation. It's where you collect all of your clinical data, analyze it, weigh it, and use it to evaluate the acceptability of your device's risk-benefit [...]

The European Union Medical Device Regulation (EU MDR) is easily one of the major changes in the last decade that altered the medical device sector in the European Union. The goal was to improve [...]

Audits are not fun. That's general knowledge. Ask anyone, and they will tell you. But they will also tell you that being audited is a normal part of being in the industry.   There are [...]

The European Medical Device Regulation (EU MDR, 2017/745) has been called many things since it was first drafted, some of which cannot be repeated here. One thing it has probably never been called is [...]

The clinical evaluation reports are the final transcript for medical devices. Allow us to explain. So, you know how in high school, you had to earn good grades and maintain a solid record to impress [...]

You want to sell your device in the European Union and start the CE marking process. But after reviewing the MDR and the guidance documentation, you begin to doubt the CE mark process.   Are [...]

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 [...]

The clinical evaluation report (CER) is crucial for medical device approval in most countries. It is a comprehensive report summarising the device's safety, performance, and effectiveness based on clinical data. The CER plays a vital [...]

The European Union Medical Device Regulation (EU MDR) has set higher standards for medical device clinical evaluation ERs) standards. With stricter regulations and guidelines, clinical evaluation report writing requires expertise, experience, and knowledge of the [...]

Obtaining the CE mark is one of the most significant milestones in the life of most medical devices. Unfortunately, it typically takes years and can exhaust even the most determined regulatory personnel. Nevertheless, getting [...]

IVDR is a separate regulation compared to the European medical devices regulation. However, it is closely associated with the regulatory authority. The PIP breast implant scandal brought to light weaknesses in the overall regulatory [...]