Mexico (COFEPRIS) Regulations For Medical Device Registration
The healthcare sector, being a dynamic and rapidly developing industry, relies heavily on medical devices to support diagnosis, treatment, and […]
MedTech
Artixio Recognizes Femicura Healthtech as GEMi Grant Winner for Innovative Medtech Solutions
Artixio proudly announces Femicura Healthtech as the recipient of the prestigious GEMi (Grant for Early-Stage Medtech Innovations). The GEMi grant,
Reprocessing Single-Use Devices in accordance with EU Medical Device Regulations (EU MDR 2017/745)
Single-Use Devices (SUDs) are indispensable in the healthcare sector, providing essential tools for medical procedures. While SUDs are originally designed
Precision Medicine – Key Players and Pipeline
Precision medicine, with its promise of tailoring treatments to individual patient characteristics, is revolutionizing the healthcare industry. By focusing on
Regulations of Reusable Medical Devices under EU MDR
The introduction of the EU Medical Device Regulation (MDR) has brought increased emphasis on robust data and comprehensive evaluations for
Post-Market Surveillance In Medical Device Regulation
One of the biggest accomplishments in the journey of a drug product is its entry into the market as a
Meeting EU Regulations: Role of the European Authorized Representative (EAR)
When foreign medical device and IVD manufacturers seek to distribute their devices within the European Union (EU) Member States, compliance
Medical Device Regulations and Registration in Canada (Health Canada)
In Canada, the medical devices are regulated by Health Canada under Health Products and Food Branch, Therapeutic Products Directorate, Medical
Class III Medical Devices: Meaning, Examples, Approval Process
FDA classifies medical devices into different categories based on their risk factor. Each class of medical device holds different rules and regulations as every one of you would