Pascal Werner – Medium

Pascal Werner

Pascal Werner

MDR for DiGA manufacturers

Overview of relevant topics for DiGA companies and what awaits them under MDR.

Jan 31, 2021

MDR for DiGA manufacturers

Jan 31, 2021

Pascal Werner

Design vs development

Translating regulatory speak for startup people.

Apr 5, 2020

Design vs development

Apr 5, 2020

Pascal Werner

Medical apps under MDR — All-in or caution?

Intention or just bad document control? Implications of the proposal to the MDR for medical apps.

Apr 5, 2020

Medical apps under MDR — All-in or caution?

Apr 5, 2020

Pascal Werner

7 questions to check the status of your medical certification

This article is written for digital health startups that currently have a MDD class I product in the market or, as some people may say, a…

Aug 1, 2019

7 questions to check the status of your medical certification

Aug 1, 2019

Pascal Werner

Classification of medical apps under MDR — it’s not the end of the world

Let’s not follow the crowd, but actually look into the law to understand what it means for your medical app.

Feb 12, 2019

Classification of medical apps under MDR — it’s not the end of the world

Feb 12, 2019

Pascal Werner

Digital health and its big challenge

Digital health companies need to focus on reimbursement and finding a business model. Regulatory work is not the core of your company.

Feb 8, 2019

Digital health and its big challenge

Feb 8, 2019

Pascal Werner

Machine learning for medical imaging analysis

Everyone talks about machine learning. Why is it not already commonly used for medical imaging analysis? What are the challenges?

Feb 7, 2019

Machine learning for medical imaging analysis

Feb 7, 2019

Pascal Werner

Current state of GDPR, part 2: how to be reasonably compliant?

How to achieve GDPR compliance without too much effort?

Jan 13, 2019

Current state of GDPR, part 2: how to be reasonably compliant?

Jan 13, 2019

Pascal Werner

Current state of GDPR — two sources of fear

Authorities are slowly starting to impose fines. And with internal compliance programs there’s an even stronger force stifling innovation.

Jan 13, 2019

Current state of GDPR — two sources of fear

Jan 13, 2019

Pascal Werner

Performance marketing vs. data privacy (GDPR)

There’s a lot of talk and articles on digital marketing and how to comply with GDPR, the recent European data privacy regulation. But…

Nov 20, 2018

Performance marketing vs. data privacy (GDPR)

Nov 20, 2018

Pascal Werner

Pascal Werner

I’m a medical engineer with digital health startup experience and write about data protection, digital health, medical product certification and holacracy.

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