The Asian Medtech Associations Regulatory Networking discussions also heard a report from the Finnish medtech regulatory advisory company Lean Entries Oy, whose CEO and founder Heikki Pitkänen described the digital assessment tool it offers. This allows companies to risk-classify their device under the EU Medical Device Regulation and In-vitro Diagnostic Device Regulation (IVDR).

The company’s remit is to help start-ups navigate the MDR, IVDR and standards at an early stage, taking into account numerous guidance documents. Pitching itself as a Nordic area specialist, it provides training and one-to-one sessions on how to get a CE-mark, dealing with notified bodies, how to deploy artificial Intelligence, and what harmonized standards are, etc.

In collaboration with ASEANMed, Lean Entries will be providing a pilot trial to the industry in the region to facilitate EU regulatory compliance and assist in EU market access for local medtech companies.

Asian Medtech Associations Reg Networking: COVID-19 Dominates As Medtechs Seek Return To Normality – Part One

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