CTM Medical Consulting

medical devices

About

At CTM Medical Consulting, we specialize in clinical, regulatory, biostatistical and medical writing consulting for Class I, IIa, IIb and III medical devices. With our extensive experience, we combine our skills and knowledge in specific therapeutic areas to research, write and execute projects with a high standard of quality. We specialize in writing clinical evaluation reports and plans from end to end, including literature searches and literature reviews. We provide support in clinical study design, protocol and report writing as well as biostatistical data analysis in support of global regulatory submissions. Our team is also highly experienced in providing guidance and updates to EU MDR 2017/745 & MEDDEV 2.7/1 revision 4.

Technologies

Gmail Google Apps Google Cloud Hosting Varnish Google Tag Manager Mobile Friendly Wix Google Analytics AI Remote IoT

Keywords

notified bodies consulting fda medical writing regulatory regulatory submissions eu mdr clinical evaluation regulatory strategy ce marking cers clinical evaluation reports cer auditing meddev rev 4 medical device medical equipment manufacturing clinical study reports clinical documentation pmcf reports services regulatory strategy support psurs clinical data collection medical device regulations medical device registration medical device quality assurance technical file review other scientific and technical consulting services medical device lifecycle management

Location

Laguna Beach, California, United States

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