HaMaDa provides a wide range of medical writing related services and offers solutions tailored to your specific needs.
HaMaDa team of medical writers bring a range of clinical and scientific backgrounds, supported by extensive industry experience and rigorous academic training.
Our teams excel in identifying, organizing, interpreting, and presenting clinical data in a precise and professional manner. Collaborating closely with our Regulatory and CRO Teams, our writers are highly responsive to individual requirements, helping our clients to achieve their objectives.
Our main services are listed below.
Regulatory Medical Writing MDR:
Required for market approval of medical devices in key markets such as Europe, and Australia. Clinical evaluation involves the systematic collection, appraisal, and analysis of clinical data related to the device. These documents undergo thorough regulatory scrutiny and require regular updates.
In accordance with the European Medical Device Regulation (MDR) EU 2017/745, we prepare Post-Market Surveillance Reports (PMSR) or Periodic Safety Update Reports (PSUR) based on the device.
According to the European Medical Device Regulation (MDR) EU 2017/745, manufacturers of implantable and class III devices must create a Summary of Safety and Clinical Performance (SSCP). This document offers public access to an updated summary of clinical data and other pertinent information about the device’s safety and clinical performance for healthcare professionals and, when relevant, patients.
Performance Evaluation Reports & Plans (PERs | PEPs), are required for market approval of in vitro diagnostic devices on the EU market (In Vitro Diagnostic Medical Device Regulation (IVDR) EU 2017/746). The Performance Evaluation report establishes the scientific validity and the analytical and the clinical performance of a device.
Preparation and submission of regulatory applications – for more information see our Regulatory Affairs page
Clinical Writing:
Preparation of essential clinical study documents, such as Study Protocols, Investigator Brochures and Clinical Study Reports
Scientific Writing:
- Clinical Literature Reviews.
- Scientific Publications.
- White Papers.
