Author: omcmedical

OMC Medical Limited pioneers streamlined license transfers for medical devices to new local Authorized Representatives (AR) in New Zealand. Our innovative approach ensures regulatory compliance and expedites market entry, empowering... Read More

Regulatory services in China and compliance with the EU Medical Device Regulation (MDR) are critical for companies like OMC Medical Limited. Operating in a global market, navigating the intricacies of... Read More

Compliance in post-marketing surveillance is paramount for OMC Medical Limited to ensure product safety and regulatory adherence. Monitoring adverse events, product complaints, and ensuring timely reporting to regulatory authorities are... Read More

OMC Medical Limited navigates the process of medical device registration in the United Arab Emirates (UAE) with precision and compliance. Understanding the significance of regulatory approval, OMC diligently follows the... Read More

Unlocking worldwide opportunities for healthcare innovation, OMC Medical Limited pioneers Global Market Access Strategies for Software as a Medical Device. Seamlessly navigating regulatory landscapes, we ensure our software meets international... Read More

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte), BfArM, is the institution responsible for regulating medical devices in Germany. Headquartered in Bonn, BfArM operates under... Read More

Introducing the Medical Device Regulation in Europe addresses several challenges. The primary objective of the MDR is to prioritize patient safety. By introducing more stringent requirements for conformity assessment, clinical... Read More