D. 29 Februar – Seminar: Regulatory challenges for healthcare apps

Did you know that your app could be classed as a medical device?


Thousands of new apps are currently being launched and many of them are targeted towards health applications. These may be classed as medical devices which means that they must be CE marked or FDA approved to achieve regulatory compliance prior to launch.


The number of new products is overwhelming and there is some lack of clarity on development and marketing of mobile devices, software and apps for tablets, Smartphones, iOS, Android etc.

Which apps and devices are classified as medical devices, how are the rules interpreted and what are the consequences if the rules are not complied to?

At the same time, medical device apps are here to stay and much in demand and business potential is more than promising.

This seminar focuses on the regulatory challenges involved in developing and marketing medical device apps.

Listen to the Danish Competent Authority (Lægemiddelstyrelsen), industry experts and cases from real life covering the challenges and pitfalls of launching apps and how to overcome them. The programme leaves room for Q&A, discussions and networking throughout the afternoon.


Delegates from SMV’s and established medtech companies with an interest in medical devices with built-in intelligence and developers of software for health technology applications including sales & marketing, regulatory affairs, quality assurance and R&D will benefit from participating in this seminar.



Wednesday 29 February 2012 11:30 – 16:30

Scion DTU, Diplomvej 372, 2800 Lyngby

Price including light lunch and refreshments:

Medtech companies with less than 50 employees, public employees or similar 1.000 dkr ex VAT (please indicate no. of employees when registering)

Members of Medicoindustrien 1.000,00 dkr ex VAT / non-members: 2.000,00 dkr ex. VAT






Nivaagaard, Gl. Strandvej 16, DK- 2990 Nivå

Tlf.: +45 4918 4708,  Mobil: +45 2284 7606

E-mail: ikh@medicoindustrien.dk

Web: www.medicoindustrien.dk