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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.
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 [...]
Software as a Medical Device
Healthcare is undergoing a paradigm shift as cutting-edge technology makes its way into medical devices, tele-health, and digital health solutions. Most modern medical devices are manufactured with integrated software and software in general has become [...]
MEDDEV 2.7.1 Revision 4: Guidelines for Clinical Evaluation
In accordance with the European directive for medical devices 93/42/EEC, ‘manufacturers must provide proof of and document the performance and safety of medical devices in a "clinical evaluation"’. With the breast implant scandal in [...]