Essential Guide to Clinical Evaluation Reports (CER) for Medical Devices

Essential Guide to Clinical Evaluation Reports (CER) for Medical Devices

Introduction In the intricate and regulated medical device manufacturing world, ensuring each product’s safety and efficacy is paramount. Clinical Evaluation Reports (CERs) are essential for demonstrating compliance with stringent safety and performance standards, especially within the European Union. These reports are a regulatory requirement and a moral obligation to guarantee patient safety. Understanding Clinical Evaluation…

The Role of Independent Authorized Representatives and License Holders for Medical Device and IVD Manufacturers Entering New Markets

The Role of Independent Authorized Representatives and License Holders for Medical Device and IVD Manufacturers Entering New Markets

The Role of Independent Authorized Representatives and License Holders for Medical Device and IVD Manufacturers Entering New Markets The intricate dance of regulatory requirements can seem daunting for medical device and in vitro diagnostic (IVD) manufacturers aiming to enter new markets. One strategic maneuver to navigate this complexity is appointing an independent authorized representative (AR)…