CTM MEDICAL CONSULTING
OUR SERVICES
Medical Writing Consulting
We have extensive knowledge and experience with creating, researching and writing clinical, regulatory and quality documents in compliance with US, EU and global medical regulations, including MEDDEV 2.7/1 revision 4, EU MDR 2017/745, and EU IVDR 2017/746. We have the capabilities to provide guidance and quality medical writing expertise to your business. Our services include: clinical study reports (CSRs), clinical evaluation reports (CERs), performance evaluation reports (PERs), post-market clinical follow-up (PMCF) reports, post-market performance follow-up (PMPF) reports, post-market surveillance (PMS) reports, periodic safety update reports (PSURs), risk/benefit analyses, summary of safety and clinical performance (SSCPs), and more.
Clinical Regulatory Submissions
At CTM Medical Consulting, we provide clinical, regulatory, and quality expertise in submission strategy and support for Class I, IIa, IIb and III medical devices, as well as class A-D in vitro diagnostic devices. Therapeutic areas in our submissions range are robust, including cardiovascular, orthopedic, ophthalmic, diabetic, and respiratory devices, as well as in-vitro diagnostic testing. With our extensive clinical, regulatory and quality network, we combine our skills and knowledge to produce high-quality submissions (CE marking, US FDA submissions) to support regulatory approval for your products. These submissions can be for new products, new indications, or for updating currently existing products.
EU Medical & In Vitro Device Regulations
(EU MDR/IVDR)
The EU MDR 2017/745 is replacing the well-known MDD and by May 2020, all products marketed in the EU will have to be MDR compliant. Following soon after is the EU IVDR 2017/746, which will require in vitro diagnostic devices to be compliant by May 2022. Medical & in vitro device companies are learning that compliance to MDR/IVDR will require significant updates to current processes and documentation in clinical, regulatory and quality functions. We can perform gap audits and pre-assessments to determine a regulatory strategy for updating your current products (technical documentation, CERs, PERs, risk management reports, PMCF reports, PMPF reports, associated plans, etc.) based on your product portfolio. We then efficiently strategize and prioritize to work towards updating your files to a compliant and sustainable state.
Technical Training
We also provide specialized on-site training in specific technical areas based on our client's needs. Get in touch to learn more about how our trainings can help you.