SPARK Finland has initiated a global pilot program on Entries, a digital platform providing “minute regulatory runways” into the European medical device directives and the new regulations, the MDR and the IVDR. The pilot covers the SPARK Global community of 60+ universities. The service is provided by Lean Entries Ltd. (www.leanentries.com), a Finnish regulatory compliance startup with substantial experience in medical device development, certification, standardisation and regulatory consulting.
According to our experience with the Finnish universities, Entries helps in making a quick regulatory status check on a medical innovation early on. The service bears great potential by steering health tech development projects to the correct direction with correct inputs from the regulatory requirements and standards, and by putting the innovators on a steep learning curve of the regulatory essentials. The goal is to boost the time to market of medical innovations through early adoption of regulatory requirements.
Two webinars will be organised on August 7th related to Entries, see the event calendar.