February 17, 2023
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 [...]
February 21, 2023
The regulatory landscape in Europe is changing. In 2021, the new medical device regulation was implemented; in 2022, it was time for the in [...]
February 18, 2023
Want to know what the most commonly criticized document in an MDR submission is? Your clinical literature review. Reviewing the literature is essential to [...]
May 23, 2023
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 [...]
May 16, 2023
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 [...]
May 2, 2023
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 [...]
April 25, 2023
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 [...]
April 18, 2023
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 [...]
April 11, 2023
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 [...]
April 4, 2023
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 [...]
March 28, 2023
CER Checklist: 12 Attributes of an Excellent CER Writer to meet the Clinical Evaluation Requirements
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 [...]
March 21, 2023
With the updates to the European Medical Device and In Vitro Diagnostic Device Regulations (MDR 2017/745 and IVDR 2017/746, respectively), the requirements for clinical evidence were increased by the regulatory authorities. 1 Part of [...]