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 helps medical device companies successfully navigate the journey from Clinical to Market (CTM). We provide comprehensive consulting services designed to accelerate development, streamline regulatory pathways, and support long-term market success.
Our expertise includes clinical evaluations, medical writing, regulatory strategy, and regulatory submissions, backed by deep experience across the medical device industry. From early-stage development through commercialization, we partner closely with our clients to deliver tailored guidance, high-quality deliverables, and efficient execution.
Beyond initial market entry, we continue to support our clients with post-market compliance, maintenance activities, and audit readiness, ensuring ongoing regulatory success.
Our clients range from Fortune 500 leaders such as Becton Dickinson, Danaher, and Johnson & Johnson, to innovative startups entering the market for the first time. No matter the stage, CTM Medical Consulting delivers the expertise, responsiveness, and quality needed to move your medical device forward with confidence.
CONTACT US
Contact us and find how our services can benefit your company.