News and Updates
Thank You for Making MEDICA 2024 an Unforgettable Experience
MEDICA 2024 has been a pivotal event for CMC Medical Devices, and we want to extend our heartfelt thanks to everyone who visited our stand and to those who graciously welcomed us at theirs. This year has been particularly [...]
When Should You Involve a CRO in Medical Device Development?
The optimal time to engage a Contract Research Organization (CRO) in your medical device’s development is as early as possible, ideally during the initial planning phase of your clinical study. Involving a CRO from the outset ensures a study design [...]
New Revision of European Medical Device Regulations: Towards Greater Transparency and Safer Access for All
In response to current challenges regarding the accessibility and safety of medical devices, the European Parliament approved a landmark resolution on October 23, 2024, to revise the regulatory framework for these products across the European Union. This urgent update to [...]
Is the TGA Sponsor Responsible for the Quality or Safety of Your Products?
What is a TGA Sponsor? A TGA sponsor is an individual or company registered with the Therapeutic Goods Administration responsible for ensuring that a product complies with Australian regulatory requirements. The sponsor acts as the official point of contact [...]
Looking for an FDA Agent? 5 Key Factors to Consider
If you’re selecting an FDA Agent for the U.S. market, certain factors can make all the difference. Here are five essential aspects to ensure you’re making a smart, strategic choice: Expertise in FDA Regulations A strong FDA Agent has [...]
What is the IFU and why is it crucial for medical devices?
When it comes to medical devices, ensuring safety, compliance, and correct usage is crucial. One key document that supports these aspects is the Instructions for Use (IFU). But what is an IFU for medical devices, and why is it [...]
Discover how to register your medical devices in Europe: an essential guide for manufacturers outside the EU!
Are you a manufacturer outside the EU and wondering how the medical device registration process works in Europe? Here’s an essential overview to guide you through the regulatory system! Step 1: Actor Registration The first step is providing key information [...]
Clinical Research in Medical Devices: What Role Does the Manufacturer Play?
Clinical research is fundamental to ensuring the safety and effectiveness of medical devices. But what are the key responsibilities of the manufacturer in this process? Here’s what you need to know: Study Design: The manufacturer must ensure that the study [...]
Exciting news! We’re heading to CMEF, the International Medical Device Fair in Shenzhen!
Join us from October 12 to 15, 2024, at the Shenzhen World Exhibition and Convention Center. Our team is excited to meet industry professionals and discuss how we can support your regulatory needs in the medical device sector. 📌 [...]
