From Good to Excellence: State of the Art Section for Medical Devices Inside-Out

Katharina Friedrich is a medical writer with experience in MDR regulatory writing. She is based in Heidelberg, Germany and works as a Freelance Medical Writing Consultant with focus on orthopedic and cardiovascular devices. She prepares Clinical Evaluation Plans and Reports, PMCF Plans and Reports and SSCPs in compliance with MDR 2017/745 for class I to class III devices. She also supports development projects and the conduction of PMCF activities. As medical doctor she has experience in the field of orthopedic and trauma surgery.

Laura is an accomplished Medical Writing Manager with a proven track record of efficiently overseeing the complete process and timely delivery of critical study documents. Her expertise encompasses a wide range of materials, including protocols, informed consent documents, clinical study reports (CSRs), and other essential study materials, particularly within the realm of pharmaceuticals. She also lends her support to medical device manufacturers in drafting crucial documents such as clinical evaluation reports, post-market clinical follow-up reports, and summaries of safety and clinical performance. Laura’s passion for clear and inclusive language extends beyond her professional duties, as she has a keen interest in public-facing writing. With over 24 years of experience, she has successfully collaborated with pharmaceutical companies and medical device manufacturers across various specialties, including oncology, orthopaedics, cardiology, dermatology, infectious diseases, and more. She regularly runs workshops on her expertise domains. Her active involvement in the European Medical Writers Organization (EMWA), where she serves as an Educational Officer and member of the Executive Committee, underscores her commitment to the field of medical writing and continuous professional development.