Pascal WernerMDR for DiGA manufacturersOverview of relevant topics for DiGA companies and what awaits them under MDR.Jan 31, 2021Jan 31, 2021
Pascal WernerDesign vs developmentTranslating regulatory speak for startup people.Apr 5, 2020Apr 5, 2020
Pascal WernerMedical 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, 2020Apr 5, 2020
Pascal Werner7 questions to check the status of your medical certificationThis 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, 2019Aug 1, 2019
Pascal WernerClassification of medical apps under MDR — it’s not the end of the worldLet’s not follow the crowd, but actually look into the law to understand what it means for your medical app.Feb 12, 20192Feb 12, 20192
Pascal WernerDigital health and its big challengeDigital health companies need to focus on reimbursement and finding a business model. Regulatory work is not the core of your company.Feb 8, 2019Feb 8, 2019
Pascal WernerMachine learning for medical imaging analysisEveryone talks about machine learning. Why is it not already commonly used for medical imaging analysis? What are the challenges?Feb 7, 2019Feb 7, 2019
Pascal WernerCurrent state of GDPR, part 2: how to be reasonably compliant?How to achieve GDPR compliance without too much effort?Jan 13, 2019Jan 13, 2019
Pascal WernerCurrent state of GDPR — two sources of fearAuthorities are slowly starting to impose fines. And with internal compliance programs there’s an even stronger force stifling innovation.Jan 13, 2019Jan 13, 2019
Pascal WernerPerformance 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, 2018Nov 20, 2018