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Category: IVD

Catherine | Associate Director Marketing for Climedo, April 28, 2022

IVDR Survey Results: What Stage of Implementation Are Manufacturers at?

The transition period will end soon: From May 26, 2022, the new European Regulation on In Vitro Diagnostics (IVDR) will become progressively applicable. In March 2022, we therefore joined forces with TRIGA-S to survey a...

IVDR Survey Results: What Stage of Implementation Are Manufacturers at?
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Benjamin Sauer | VP Engineering for Climedo, 20. April 2022

New Rules for Market Access of In Vitro Diagnostic Devices: How Do the Old IVDD and New IVDR differ?

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New Rules for Market Access of In Vitro Diagnostic Devices: How Do the Old IVDD and New IVDR differ?

Catherine | Associate Director Marketing for Climedo, 10. August 2021

Complete list of IVDR certified Notified Bodies

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Complete list of IVDR certified Notified Bodies

Catherine | Associate Director Marketing for Climedo, 02. July 2021

1, 2, 3… MedTech Connect, Round 3: IVDR as an Opportunity

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1, 2, 3… MedTech Connect, Round 3: IVDR as an Opportunity
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CLIMEDO IN THE NEWS

The impact of cineole treatment timing on common cold duration and symptoms: Non-randomized exploratory clinical trial Revolutionizing Clinical Trials: Physicians Embrace Digitalization for Scientific Advancement Survey reveals insights into physicians' perspectives on clinical trials and digitalization 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'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