Heikki Pitkänen

CEO & Founder

Heikki Pitkänen has 16 years of experience in the medical device industry, with five of those as a team leader in notified bodies and accredited certification bodies. He is the founder of Lean Entries, Ltd., and a member of the Advisory Board for Healthcare Standards of CEN-CENELEC.    


1 blog from the author


Posted on 06.09.2017

The challenges of a MedTech startup in the land of scattered Regulatory Information

According to the preliminary results of a study* aimed at the Finnish medical device industry, regulatory compliance pops up as the second biggest challenge burdening the industry. This, according to the study, comes in the wake of challenges for establishing effective international distributor channels. To me, this only verifies what I have experienced working in […]

By Heikki Pitkänen CEO & Founder