Heikki Pitkänen Föreläsare

CEO & Founder
Lean Entries Ltd

Föreläsare för

Qualification, Classification and Current EU and US Requirements for Medical Device Software

Onsdag 09:00 - 10:00 Medicintekniska regelverk

Heikki is the CEO and founder of Lean Entries Ltd., a group of regulatory experts in the area of global medical device regulations providing unique digital regulatory services, named Entries (at www.leanentries.com). They also provide traditional consulting for the medtech sector from academies and startups to multinational enterprises. Heikki has two decades of experience from medical device development, standardisation, accredited testing and certification, most lately as the Notified Body site manager at SGS. He is a member of the CEN-CENELEC Advisory Board for Healthcare Standards and speaks on regulatory compliance internationally.

Personlig presentation
Heikki is the CEO and founder of Lean Entries Ltd., a group of regulatory experts in the area of global medical device regulations providing unique digital regulatory services Entries (at www.leanentries.com). They also provide traditional consulting for the medtech sector from academies and startups to multinational enterprises. Heikki has two decades of experience from medical device development, standardisation, accredited testing and certification, most lately as the Notified Body site manager at SGS. He is a member of the CEN-CENELEC Advisory Board for Healthcare Standards and speaks on regulatory compliance internationally.