The FDA has recently published a Recommended Acceptable Limit guidance document for nitrosamine impurities in drug products....
Creating an easy to follow, interesting, conference presentation is always the goal of conference attendees, but quite...
Scientific writers can help you with your clinical evaluation needs. Clinical evaluation is an ongoing requirement for...
A clinical evaluation plan (CEP) may be necessary for your device. A medical device manufacturer that sells...
A Clinical Evaluation Report (CER) is a detailed summary of the evaluation of information pertaining to clinical...
FDA Warning Letters are devastating – a Quality Manager’s worst nightmare – a major shock to any...
Compared to the Medical Device Directive (MDD) 93/42/EEC, the Medical Device Regulation (MDR) No. 2017/745 introduces a...
Understanding the classification of your medical device before CE marking is a critical step as it affects...
To maintain compliance with heightened requirements under the Medical Device Directive (i.e., recent Notified Body implementation of...
In medical science reporting, ghostwriting has a bad rep. Deservedly so, in many cases. Why is this...
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