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Latest Publications
Look here for Industry updates and technical tutorials written by the CiteMed staff. All things Medical Device Regulation are covered in our publications.
Analyzing the Differences between CERs for MDR versus MDD
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. [...]
Post Market Surveillance Under the EU MDR
There are only a handful of explicit things that you MUST do for Post Market Surveillance under the European Medical Device Regulation (MDR 2017/745); however, there are many things you SHOULD be doing to continuously [...]
Publishing Clinical Trials Results in Journals
Clinical trials are a crucial piece of launching a medical device. Publishing the data you have gathered regarding the safety and effectiveness of your product is the first step of proving its quality attributes. [...]
MEDDEV 2.7.1 Revision 4: Guidelines for Literature Search
The MEDDEV 2.7.1 is the most important technical guidance document for literature search under the MDR in the medical device regulatory industry. Since the MDCG documents do not currently offer any concrete guidance on [...]
Effectively Handling Corrective and Preventive Actions (CAPA) Process with EU MDR
The EU MDR emphasizes field safety corrective actions to correct non-conformances of the distributed product, but since these principles are used throughout the quality system, they are not limited to the distributed product alone. Preventive [...]
Clinical Evaluation Report (CER) Writing for Small Manufacturers
While larger manufacturers, global players, and multinational companies most likely won’t have problems complying with the European MDR due to having both the financial and human resources to comply in time, smaller and medium-sized [...]