Selection of a Notified Body and Their Process for your new device authority
Notified Bodies an overview: You must have your device CE marked before you may market it in the European Union. Additionally, medical device manufacturers
Notified Bodies an overview: You must have your device CE marked before you may market it in the European Union. Additionally, medical device manufacturers
Over the course of more than 20 years in regulatory affairs and quality consistency, we’ve discovered how difficult it can be to implement a
Introduction Quality and Regulatory Affairs is a profession that came from governments’ desire to protect public health by ensuring the security and adequacy of
Introduction In the ever-evolving landscape of medical device regulation, obtaining approval for In Vitro Diagnostic Devices (IVDs) can be a complex and daunting task.
When it comes to medical devices, safety and hygiene are of most importance. Ensuring that medical devices are free from harmful microorganisms and safe
Post Market Clinical Follow (PMCF) up is an effective method that constantly helps to monitor the clinical evaluation results. This assessment and examination of