CTM Medical Consulting

CTM Medical Consulting provides medical writing and regulatory consulting services for medical device companies navigating US FDA and EU regulatory pathways. The firm specializes in clinical documentation, regulatory submissions, and compliance with EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.

The consultancy offers expertise across all device risk classifications (Class I through III, and IVD Class A-D) in therapeutic areas including cardiovascular, orthopedic, ophthalmic, diabetic, and respiratory devices. Core services include clinical evaluation reports, performance evaluation reports, post-market surveillance documentation, 510(k) submissions, PMAs, and gap audits for MDR/IVDR transition.

CTM Medical Consulting works with clients from initial clinical development through market approval and ongoing compliance activities. The firm maintains a clinical, regulatory, and quality network to support submission strategies and provides on-site technical training customized to client needs.

CTM Medical Consulting serves medical device companies needing specialized regulatory writing expertise without maintaining full-time regulatory staff. The firm's focus on EU MDR/IVDR transition makes it particularly relevant for companies with legacy European certifications requiring updates to meet current regulations.

Clients can expect support ranging from single document preparation to comprehensive gap assessments and remediation planning. The consultancy's multi-therapeutic area experience and network approach provide access to specialized knowledge across different device types and regulatory pathways.

CTM Medical Consulting operates exclusively in the medical device sector, providing regulatory and clinical documentation services that enable manufacturers to obtain and maintain market authorization. The firm's healthcare focus centers on compliance with medical device regulations in the US and EU, with particular depth in EU MDR and IVDR requirements that govern device safety and clinical evidence.

Therapeutic area expertise spans cardiovascular, orthopedic, ophthalmic, diabetic, and respiratory devices, as well as in vitro diagnostic testing, demonstrating healthcare specialization across multiple clinical domains and device risk classifications.

Medical device manufacturers of Class I-III or IVD devices seeking regulatory consulting for US FDA or EU submissions, particularly those undergoing MDR/IVDR transition. Companies without dedicated regulatory writing staff or those needing specialized expertise in cardiovascular, orthopedic, ophthalmic, diabetic, or respiratory device categories will find aligned capabilities.