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News and whitepapers

Episode 4 – NOTIFIED BODIES, EUDAMED & MRA

In this follow-up episode of MDR-podden, your host Sofia Nordgren and Helena D., Head of Department for Medical Devices at the Medical Products Agency, discuss topics such as the designation of notified bodies, EUDAMED and how Brexit and the lack of mutual recognition agreement with Switzerland affect our medical technology companies. Listen to the episode on […]

Episode 3 of MDR-podden – Strategic advantage or necessary evil?

In this episode, Sofia Nordgren is visited by Per Hedman, Partner at Cirio Law Firm to discuss how companies can transform the requirements of the MDR to a competitive advantage and possible trends resulting from the implementation of the new regulation. Listen to the episode on Spotify: Or in your browser MDR-Podden is a collaboration […]

Our CEO Sofia Nordgren – part of the mentor team at DigitalWell Ventures

We are proud that our CEO Sofia Nordgren is a part of the mentor team at DigitalWell Ventures

JOIN THE KICKFILE TEAM

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YESTERDAY IN SWEDENBIO’S PODCAST STUDIO

Yesterday SwedenBIO‘s podcast studio, our Chief Compliance and Regulatory Officer Sofia Nordgren and her guest Per Hedman, partner at Cirio Law Firm, discussed how companies can use MDR as a competitive advantage. Stay tuned for the next episode of MDR podden – the podcast that helps you navigate through the MDR

2 Episode of MDR-podden – National implementation

Don’t miss out on the second episode of the MDR podcast that Kickfile and Devicia together with SwedenBIO! In this episode, Sofia Nordgren is visited by Helena D., Head of Department for Medical Devices at the Swedish Medical Products Agency. They cover the role of the Medical Products Agency, national legislation and the strict regulation all Medtech companies most follow… Listen to the […]

Kickfile in Dagens Industri

Today you can read about or Sofia Nordgren, CEO at Kickfile and CCRO at Devicia AB – Your Medical Device CRO in Dagens industri. Sofia shares the idea behind the recently released MDR-podden that she has initiated together with SwedenBIO, her advice on how to tackle the lack of Notified Bodies that are qualified under […]

MDR PODDEN – HEAD OF DEPARTMENT FOR MEDICAL DEVICES AT THE SWEDISH MEDICAL PRODUCTS AGENCY IN THE STUDIO

In SwedenBIO‘s podcast studio, our CEO Sofia Nordgren is accompanied by Helena D., Head of Department for Medical Devices at the Swedish Medical Products Agency at the recording of the second episode of MDR podden. Stay tuned for the next episode of MDR podden – the podcast that helps you navigate through the MDR.