CTM MEDICAL CONSULTING
Medical Writing Consulting
Expert Guidance
We have extensive knowledge with US, EU and global medical regulations including MEDDEV 2.7/1 revision 4, EU MDR 2017/745 and EU IVDR 2017/746. With years of experience in the medical device industry, we have the capabilities to provide guidance and quality medical writing expertise to your business.
Clinical & Regulatory Submissions
Get Your Devices Approved
At CTM Medical Consulting, we specialize in clinical, regulatory and medical writing for all risk class devices. With our extensive clinical and regulatory network, we combine our skills and knowledge in therapeutic areas to research, write and produce CSRs, CERs, PERs, PSURs, PMAs, 510(k)s, and training to update your products and to help your business obtain regulatory approval for your products.
EU MDR & IVDR Compliance
Gap Audits & Transition Support
We specialize in gap pre-assessments and auditing of current documentation against EU MDR 2017/745 and EU IVDR 2017/746. We provide transition support and remediation of technical documentation, CERs, PERs, PMCF reports, risk-benefit analysis forms, etc. We can also create plans for clinical evaluations, PMS and PMCF.
ABOUT CTM
CTM Medical Consulting offers consulting services in support of bringing medical devices from Clinical to Market (CTM). Our services include clinical evaluations, medical writing, and regulatory strategies and submissions with a wide range of expertise in the medical device industry. We partner with our clients from start to finish, focusing on their needs while providing expert guidance and producing quality work. We also support our long-term clients in maintenance activities for market compliance as well as providing audit support.
CONTACT US
Contact us and find how our services can benefit your company.