Clinical Evaluation Reports – CER

So you’ve taken a look at EU MDR transitions for some of your devices and shopped around for quotes on help writing the technical file. One of the more common tasks is taking a look [...]

Thinking of Hiring a Clinical Evaluation Consultant? So it's finally time to either start that new Clinical Evaluation Report (CER) project for Europe, or remediate your current documents based on Notified Body feedback... and [...]

Medical device regulation is important. Not just because we work with them. But because they control and regulate devices that diagnose, treat, and monitor literally all health disorders. And for this very reason, no [...]

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 [...]

Developing a medical device is not a one-step process. There are hundreds of little steps, from drawing the design to finalizing it to actually creating the device. Between all these steps, there is always [...]

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 [...]

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 [...]

Are you shopping for CER writers? Or perhaps trying to evaluate if this is the type of document you can make work yourself? Then this article is for you. With the transition to [...]

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 [...]