Blog
Beyond Pharma.. Medical Writing’s Expanding Horizons in MedTech and Combination Products
Author: Pawandeep Kaur Bollinger, PhD
Medical writing is often associated with pharmaceuticals, but its impact stretches far beyond. In the MedTech and combination product sectors, where innovation meets stringent regulatory demands, medical writing serves as the backbone of product development, compliance, and market success. This blog explores how specialized medical writing empowers MedTech companies to navigate complex regulatory landscapes, enhance communication with notified bodies, and drive patient safety.
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Ensuring Quality in Healthcare: A Deep Dive into WHO’s Good Storage and Distribution Practices for Medical Products
The Mysteries of Medical Device Performance Requirements
Author: Pawandeep Kaur Bollinger, PhD
In the realm of medical devices, performance requirements are shrouded in a veil of complexity and rigor. These requirements are not merely checkboxes to tick off but are intricate standards designed to ensure that devices perform reliably and safely under various conditions. As manufacturers navigate the labyrinth of regulatory compliance, understanding and meeting these performance requirements becomes paramount.
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Early Feasibility Studies for Medical Devices Under EU MDR: Harmonization, Challenges, and Future Directions
Author: Pawandeep Kaur Bollinger, PhD
Early feasibility studies (EFS) are critical for accelerating the development of innovative medical devices, particularly under the EU Medical Device Regulation (MDR). These studies provide preliminary safety and performance data, enabling developers to iterate designs and address risks before full-scale clinical trials. However, the harmonization of EFS frameworks remains a challenge in Europe. This blog explores the current landscape, highlights collaborative initiatives, identifies gaps, and offers perspectives for improvement.
Navigating MDR and IVDR Compliance: Five Crucial Questions Answered
Author: Pawandeep Kaur Bollinger, PhD
As the deadlines for the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) approach, companies must act swiftly to ensure compliance. Here are five critical questions and answers to guide your preparation and highlight the importance of engaging a regulatory expert early on.
Read more: Navigating MDR and IVDR Compliance: Five Crucial Questions Answered