This includes classifying your device, making sure it meets the correct set of regulations, as well as protecting the medical device’s IP and building an IP strategy.
We'll be there when you are monitoring the safety and quality of your product. When you're ready to look at commercial opportunities, we can share our knowledge on labeling, purchasing, manufacturing, importing and distribution, licensing, freedom to operate, and product monetization.
Whether you are a university research department or a large international business looking to acquire or invest in a medical device company, our global team of lawyers can guide you through how the regulations in different markets will apply to your work. We can give you practical advice, including speaking to EU notified bodies.
Our team in the US has particularly strong experience in IP protection. We can help you assess your patent, procure your patent portfolio and enforce it against would-be competitors with the knowledge and understanding that stems from our lawyers’ technical science and engineering backgrounds and training.
We can also help you move quickly. When a technology company with no previous medical experience came to us with a Covid-19 test device, we were able to assemble a team of data, privacy lawyers, commercial lawyers, regulatory lawyers, and IP lawyers within a few days.
Ultimately, our goals are the same as yours. We'll protect your interests while helping your organization and your device create a global impact.
Our team has great experience in the area of medical devices, including:
- representing a European venture fund in the purchase and divestiture of a global heart valve company
- representing a large global medical device company around the world on a broad range of legal matters - lawyers from our offices throughout Asia, Europe, and the US collaborated to provide services in key jurisdictions including Australia, Canada, France, Hong Kong, the UK and the US
- providing global IP portfolio management for many dozens of companies across various technologies including structural heart devices, prosthetic heart valves, catheters, stents, shunts, orthopedics, ablation devices, neurostimulation systems, drug delivery, pumps, biomaterials, etc.
- conducting an internal investigation of the German and Italian subsidiaries of a multinational medical device company for suspected FCPA violations
- assessing mobile apps as medical devices and providing advice on classification on behalf of many clients
- litigating for the inventor of a pediatric emergency transport device
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Global Health and Life Sciences Newsletter Edition 11