Nav­i­gat­ing Reg­u­la­tions for MedTech includ­ing MDR/IVDR, AI Act, Data Act and EHDS, Webi­nar

This hands-on ses­sion demys­ti­fies the reg­u­la­to­ry land­scape for MedTech and SaaS health­care prod­ucts. Par­tic­i­pants will work through case stud­ies to iden­ti­fy applic­a­ble reg­u­la­tions, under­stand your com­pli­ance require­ments , and map out path­ways for prod­uct cer­ti­fi­ca­tion and mar­ket entry.

Date: May 13^th, 2025
Time: 10:00 – 11:30
Reg­is­ter here.
Pre­sen­ters: San­dra Liede (Tech­nol­o­gy Indus­tries of Fin­land), Heik­ki Pitkä­nen (Lean Entries), Kir­si Korho­nen (Kor­si Key)
Host: Busi­ness Tam­pere

This event is part of Health­Hub Finland’s train­ing and edu­ca­tion ser­vices and is free of charge.

Pro­gram

10:00 – 10:05 Wel­com­ing words Busi­ness Tam­pere

10:05 – 10:20 How to apply mul­ti­ple reg­u­la­tion require­ments and cre­ate sol­id reg­u­la­tion strat­e­gy?

• San­dra Liede, HealthTech Fin­land

10:20 – 10:55 New tool to nav­i­gate EHDS (Euro­pean Health Data Space) reg­u­la­tion

• Heik­ki Pitkä­nen, Lean Entries   

10:55 – 11:20 How to imple­ment reg­u­la­to­ry com­pli­ance in prac­tice for a Soft­ware as a Med­ical Device

• Kir­si Korho­nen, Kor­si Key

Source: Health­Hub Fin­land EDIH

Con­tact per­son:
Hen­rik Honka­nen
henrik.honkanen@businessturku.fi