Our internationally recognized medical technology practice advises leading established as well as startup innovative medical devices companies in relation to a full range of commercial, regulatory and contentious matters. Matters include borderline and classification disputes, CE marking and post market surveillance related matters, language and labeling matters, adverse incident reporting, incident handling and complaints, parallel imports, reviewing marketing and advertising materials. Clients welcome our deep understanding of the sector and regulatory framework and our out of the box thinking to support innovative and challenging products that push the boundaries of law and policy. We are deeply involved in EU and national developments of law and policy and sit on several European Commission committees concerning new medical technology and mobile health We assist clients with M&A transactions, regulatory matters, disputes involving labeling and public affairs, e.g. surrounding the EU Medical Devices Regulation proposal. Excellent contacts with authorities on national and EU level allow us to address contentious issues quickly and efficiently.
Life sciences regulation is international, complex and always changing. Our team makes sure that you...
The compliance stakes that a company may face in the life sciences field are high,...
Whatever the activity, partnerships or business deal - commercial contracts are needed to ensure the...
Intellectual property rights are at the core of the life sciences industry. They are the...
If a company wants to acquire another company, intends to grant a license, or wants...
Companies in the biotech industry are highly dependent on funding in the form of equity,...
We know from experience that a fresh external view on strategic issues considerably benefits a...
Research and development and license agreements are essential in the life sciences field. From experience...
We have coached numerous scientific founders and knowledge institutes during spinning out inventions and intellectual...
Building on our thorough understanding of both the IVD sector and the (inter)national regulatory framework,...
Our internationally recognized medical technology practice advises leading established as well as startup innovative medical...
We advise a large number of companies and institutions active in pharmaceuticals, medical devices and...
In the fast expanding market for eHealth, mHealth and telemedicine, we provide our clients with...