5 Regulatory Challenges in Software Medical Devices Software is increasingly at the core of modern medical devices. From diagnostic tools powered by AI to mobile health apps tracking vital signs, software-based medical devices are transforming healthcare delivery. But with innovation comes regulatory challenges in software-based medical devices. Manufacturers, developers, and legal teams must navigate a...
Post-Market Surveillance (PMS) is the ongoing process of monitoring a product’s performance, safety, and compliance after it has been released into the market. Common in the medical device and pharmaceutical sectors, PMS ensures that products continue to meet regulatory and safety standards throughout their life cycle. It includes collecting data, analyzing feedback, and responding to...
Confused by EU MDR compliance for Class I medical devices? This FAQ covers CE marking, QMS, post-market surveillance, and documentation basics.
Discover 7 compliance risks when selling healthcare tech internationally—from FDA/CE approvals to data privacy and anti-bribery laws.
Egyptian exporter of Class I medical devices passed the EU MDR audit by overhauling legal documents and distributor agreements. Learn how.
Need to register a medical device in Egypt before export? This guide covers classification, documentation, and EDA approval steps.
Exporting medical devices? Don’t ship without these 10 critical legal documents. A practical list for manufacturers, exporters, and consultants.
This image reflects the legal compliance process for exporting medical devices to Egypt, including product registration, customs, IP, and distribution terms.