CTM Medical Consulting provides regulatory strategy & medical writing services. Our team consists of highly experienced medical writers and professionals in clinical, regulatory and quality, specializing in various therapeutic areas in medical devices, combination devices, and software as medical devices (SaMD) for class I – III products.

 

Expertise in specific provisions include and are not limited to: technical files, clinical evaluation reports and plans (CER, CEP), clinical study reports, literature searches and reviews, biostatistics, post-market surveillance, new product development, and various technical support for US & OUS regulatory submissions. We specialize in providing compliance with regulations and guidances such as EU MDR 2017/745, MEDDEV 2.7/1 revision 4, MDCG, EN ISO standards, etc. Our team has led numerous clients to success in the global markets. Our client base ranges from small start-ups to Fortune 100 companies.

 

In recent years, CER requirements have increased. Notified bodies and regulatory agencies are reviewing CERs more stringently and with higher expectations. Our team of consultants is highly specialized in providing high-quality CERs for new devices going from clinical-to-market or even legacy devices requiring retrospective collection of data for demonstration of conformity and continued ongoing post-market surveillance.

CTM Medical Consulting is led by CEO & President, Carolyn McCuan, a consultant with over 18 years of experience in managing and writing clinical, regulatory, quality and scientific documents. Carolyn has experience in leading clinical & regulatory teams through several successful new product/indication submissions (PMA and Class I-III CE Mark submissions) and 100+ annual reports, including clinical study reports. In addition, she has fully authored and completed over 100 CERs under MEDDEV 2.7/1 rev. 4 and EU MDR with various clients, remediated risk management plans and reports, and risk-benefit analyses. She has successfully led manufacturers through notified body & FDA audits by providing expert guidance for strategy and by providing necessary support to address audit findings. Carolyn received a Master’s in Molecular Biology from The University of Southern California and a Bachelor’s in Biological Sciences from The University of California, Irvine.

 

Carolyn works directly with her team and the clients to provide clinical, regulatory and quality expertise, medical writing support, project management, and streamlined communication for all projects. Currently, 100% of work submitted has been satisfactorily accepted by the notified bodies and regulatory agencies.