Regulatory support

There are three working groups:

Health Software and Data (TOD), Chaired by Mika Siitonen, Labquality Oy
Medical Devices (MD), Chaired by Hannele Toroi, Coroi Oy
In Vitro Diagnostic Equipment (IVD), Chaired by Tiina Riihimäki, PharmaLex Finland Oy

The main language in the working groups is Finnish, but presentations may be held in English depending on the specialists and the subject. In addition to working groups, the association organizes monthly regulatory updates in English. These meetings are organized via Teams and cover current regulatory matters.

The Chair, the Secretary and the representative of the Healthtech will be present at the meetings. Participants of the working groups have no obligations, the questions are welcome and the participants are welcome to join the discussion.

The secretary of the meetings is Päivi Ahlgren, Healthtech Finland, the working groups are coordinated by Sandra Liede, Healthtech Finland.

Competition legislation

We take into account the competition legislation in our meetings, since our member companies who are present at the meetings, are working in the same field of business with each other or operating in the same distribution chain.

Assemblage

Participants are, for example, regulatory, quality and product development experts from companies and notified bodies. The working groups have a positive atmosphere of cooperation. The common legal challenges bring experts from large export companies and small startups together.

The working groups bring experts  from outside of the association, such as representatives of the competent authorities. Through the working groups, member companies receive the latest news from authorities, for example, current issues in the field in the EU, national law drafting or implementing laws and regulations.