Medical Devices

The implementation of the Medical Device Regulations (MDR) and In Vitro Diagnostic Medical Device Regulations (IVDR) increases the regulatory writing requirements for medical devices. Morula Health’s medical writers have a comprehensive understanding of a range of medical devices and relevant global regulations.

We can help ensure timelines are met and devices are brought to market as quickly as possible.

Clinical Evaluation Reports (CERs)

Clinical Evaluation Plans(CEPs) 

Clinical Literature Reviews 

Periodic Safety Update Reports (PSURs)

Post-Market Surveillance Reports (PMSRs) 

Summaries of Safety & Clinical Performance (SSCPs) 

Clinical investigation plans (CIP)

Clinical Investigation reports (CIR) 

Investigator brochure (IB) 

Informed Consent Form (ICF)