The Emerging Medtech Summit 2020, organized by Life Science Intelligence, saw over 100 innovative medical technology startups from a multitude of medical modalities present their cutting-edge innovative technology and their plan for growth to gain strategic partnering and investment. The event...
Annex I under the EU MDR, General Safety and Performance Requirements, outlines some broad requirements that are applicable to all devices. Manufacturers need to carefully read and understand each requirement since only some of them will apply to any given...
How does gene therapy fit into the FDA? Is it a medical device, a drug, or a combination product? What if gene therapy can cure a life-threatening disease? There are a lot of questions that can pop into your mind...
Are you looking to expand your consumer base and grow your business? International marketing is beneficial by creating long-term business relationships and increasing brand reputation. Expanding your market to a country like Australia is a smart commercial move, but how...
The up-classification of devices under the new EU MDR has definitely put some manufacturers in a very difficult situation. This is true especially for manufacturers of class I devices that have now been up-classified under the new EU MDR. Under the...
For manufacturers of medical devices, it can be an easy trap to fall into only focusing on the compliance of your device and forgetting your supply chain. The FDA has strict regulations around Purchase Controls (supplier management) that are outlined...
The new European Medical Device Regulations and the In Vitro Diagnostic Devices regulation have a lot emphasis on the post-market activities that a manufacturer must undertake. With the clock ticking fast to meet the deadline for the transition period, which...
One of the major changes with the EU MDR that medical device manufacturers will feel as they transition to comply with the new regulation is the change in requirements for device classification. As medical device classifications change so do the...
A 510(k) is the most utilized regulatory pathway to market a medical device in the US. For a device of the same level of risks, a CE Mark is required to market a medical device in the European Economic area. In...
If you’re considering selling your medical device in Europe, you will need a Notified Body, and you’ll need to understand what role they play in making sure your device is compliant to the EU regulations. A Notified Body is an...