Approval
The approval of your (digital) medical device, such as a health app, requires not only regulatory expertise, but also specialized legal advice. Not only in the early stages of product development does it matter how a device is to be legally classified, which risk class is relevant and how to communicate skillfully and effectively with the authorities, such as the BfArM. Even in ongoing sales, questions of regulatory law can arise again and again, which must be dealt with effectively and in a targeted manner.
On the way from the idea to CE marking, Vorberg.Law advises you on your product in all regulatory and legal matters in an optimally coordinated cooperation with QuR.digital always where you need it.
Reimbursement
Many manufacturers seek reimbursement for their products from statutory health insurers (SHI). Numerous new opportunities have arisen in recent years, particularly for digital medical devices. Whether as DiGA (digital health application), DiPA (digital care application) or assistive device – the legal conditions are currently better than ever.
In order to sound out legal classification and possibilities for your product in the best possible way and to accompany you in setting the right course, it is better to ask for our expertise sooner rather than later. In this way, you are well positioned right from the start, and with our help and in an optimally coordinated cooperation with QuR.digital, you can ensure that you achieve your goal of reimbursement by the SHI, e.g., inclusion in the DiGA directory, in the best possible way.
For workshops, roadmaps and strategic statements, we are also happy to provide precise calculations for our time and costs in advance to enable you to plan in the best possible way.
Compliance/Advertising
Advertising campaign planned? Checking of website texts? Received warnings?
The law on the advertising of medicinal devices is full of pitfalls that can get you into a lot of trouble, but you don’t have to! The same applies, for example, to medical professional law. Can I set up my business model as a GmbH and hire doctors for it?
Vorberg.Law has its finger on the pulse of time and accompanies not only up-and-coming startups with disruptive ideas, but also traditional companies in the healthcare sector on all issues of compliance and advertising law.
Contract/Conflict
Many legal relationships are regulated in individual contracts: employment, cooperation between two companies, but also, for example, the relationship of the app manufacturer to the health insurance company in highly specialized 140a contracts on special care.
Vorberg.Law has extensive expertise in the field of contract drafting and always keeps an eye on the latest developments in this area. We also draft AGB (general terms and conditions) individually in close coordination with your product and offer.
And in the event of a contentious conflict, we know how to develop solutions for you with objectivity and extensive experience in drafting pleadings, and how to advocate for the best possible implementation in an appropriate manner.
