Scientific articles and reports published in peer reviewed scientific literature related to either the device under evaluation, or a device for which equivalence to the device under evaluation can be demonstrated, Clinically relevant information coming from post-market s...
The SSCP is intended to provide public access to an updated summary of clinical data and other information about the safety and clinical performance of the medical device. The SSCP will be an important source of information for intended users – both healthcare professionals and if relevant for p...
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Utilized in the full life-cycle clinical evaluation of medical devices for the treatment of patients with rare diseases with shortened time to market Support post-market surveillance At this stage, the RWD can only serve as supplementary information and cannot yet fully replace the existing clinical...
Some of the key things that medical device manufacturers need to consider in a questionnaire to run an end-user survey include: · Device type – name, diagnostic or therapy area · End-user information – speciality type and screening criteria ...
With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and qua...
Cardinal Health Regulatory Sciences has more than 150 regulatory and clinical affairs consultants who have an average of 20 years of regulatory experience. We’ve worked with all divisions of the FDA throughout the FDA approval process, in all therapeutic markets, and...
ICU Medical’s system operating manuals provide basic operating information as well as advanced therapies and features. They also include important safety information for both the operator and the patient. To view inactive or previously published versions of the current ...
To the extent this site contains information, reference guides and databases intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. Prior to use, please consult device labeling for prescriptive information and operating instructions....