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In unserem Blog finden Sie Trends und Neuigkeiten rund um MedTech, EU-MDR, klinische Studien und Digital Health und bleiben Sie bei Änderungen regulatorischer Anforderungen immer auf dem aktuellsten Stand.

Category: Audits

Tereza | Senior Customer Success Manager for Climedo, January 04, 2022

3 Success Factors that Determine the Course of Phase IV Trials

Checklist for clinical trials:

  • Ethical requirements (Medicinal Products Act, Medical Devices Act)
  • Authorization by authorities
  • Endorsement by an Ethics Committee
    • ...

3 Success Factors that Determine the Course of Phase IV Trials
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Veronika | Co-Founder & COO for Climedo, 10. December 2021

Climedo Connect: The digital patient – Data protection in the healthcare sector

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Climedo Connect: The digital patient – Data protection in the healthcare sector

Catherine | Marketing Lead for Climedo, 10. August 2021

Complete list of IVDR certified Notified Bodies

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Complete list of IVDR certified Notified Bodies

Veronika | Co-Founder & COO for Climedo, 05. January 2021

Virtual Audits under EU MDR – What You Need to Know

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Virtual Audits under EU MDR – What You Need to Know

Jan Graf | qtec group for Climedo, 01. August 2020

Verification versus validation – what’s the difference?

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Verification versus validation – what’s the difference?

Dragan | Co-Founder & CTO for Climedo, 18. May 2020

Preparing for Unannounced Audits by Notified Bodies under the EU MDR 

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Preparing for Unannounced Audits by Notified Bodies under the EU MDR 

Dennie Rothbächer I Head of Business Development for Climedo, 15. October 2019

How Will the EU MDR Shape the Future of MedTech?

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How Will the EU MDR Shape the Future of MedTech?
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CLIMEDO IN THE NEWS

Climedo's survey about the patient perspective on clinical trials featured by Labiotech RAPS: Outlook for clinical trials: Digital and patient centric. Regulatory Focus. A guest article by Veronika Schweighart in Tagesspiegel Background (in German) Climedo is sponsoring ACDM's DCT Symposium in Amsterdam this June Climedo's blog among the Top 80 European Healthcare Blogs People behind healthcare innovation: McKinsey Interview Climedo publishes new ePRO expert guide Climedo wins 2nd place for the Deloitte Fast 50 Award Climedo is among the "Health Tech Challengers" finalists Business Model Configurations in Digital Healthcare – a German Case Study about Digital Transformation Majority of diagnostic companies still implementing IVDR as deadline nears German healthtech startup Climedo picks up €5 million funding boost Outsourcing-Pharma: Survey: research industry keen on DCT benefits, slow to adopt Outsourcing-Pharma: Survey seeks to chart adoption of decentralized trials, future plans RAPS: Challenges and opportunities in medical device clinical trials in Europe CenterWatch: European Trials Lag Behind U.S. in Decentralization, Survey Finds Outsourcing-Pharma: Report reveals obstacles to implementing digital trial tech Healthcare Global: A guide to labelling compliance for medical devices Easy Medical Device: EU MDR Survey: What is the Industry’s opinion? RAPS: EU MDR Countdown: Readiness of medtech companies in Europe EPR: How small medical device manufacturers can achieve cost-effective compliant labelling MedTech Dive: EU MDR delay has not made new rules easier to stomach: exec poll RAPS: EU MDR survey: Time investment, costs, and personnel resources Easy Medical Device: What is the cost of an EU MDR project? Podcast: What is the true cost of the EU MDR? MedTech Insight: EU MDR Compliance Will Cost More Than 5% Of Revenues For Half Of Medtechs, Survey Says MedTechDive: EU MDR costing smaller medtechs 5% of their annual sales: survey Zollhof: Climedo’s digital symptom diary supported by Germany’s Federal Ministry of Health Helping MedTech companies comply with EU MDR: A case study Climedo Named Winner of EIT Health’s Headstart Program Medical Plastics News: How Covid-19 is impacting the medtech industry Survey results suggest medtech companies are not ready for EU MDR EIT Health: COVID-19 – Response from EIT Health Germany community