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366 results:
South Korea: An interesting market for medical device manufacturers  
South Korea: An interesting market for medical device manufacturers A German medical technology industry analysis from 2020 estimated the market for medical devices in South Korea at USD 6.7 billio  
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Substance-Based Medical Devices: What You Have to Do to Be Able to Continue Marketing Your Existing Devices Under The MDR  
Substance-based medical devices: What you need to do now in order to continue marketing your legacy device under the MDR Manufacturers of medical devices such as seawater nasal sprays, mucous membr  
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Regulatory Affairs  
Articles on regulatory affairs  
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Jobs at Johner Institute  
Dream jobs at Johner Institute Become part of our great team! Our more than 150 colleagues at the Johner Institute work hand in hand to fulfill our mission every day: We support manufacturers of m  
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Seminar Medical Device Consultant MPDG  
Seminar Medical Device Consultant MPDG The German and Austrian Medical Devices Act MPG require the role of the Medical Device Consultant (also called Medical Device Advisor, or Medizinprodukteberat  
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PMCF studies: three types to be distinguished  
PMCF studies: three types to be distinguished PMCF studies are studies that manufacturers use as part of post-market clinical follow-up to continuously demonstrate compliance of their medical devic  
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Brexit: How you can still sell your medical devices in the UK  
Brexit: How you can still sell your medical devices in the UK   Brexit was completed in January 2021. What was a cause for celebration for some means an additional burden for many - including  
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ASCA Accreditation Scheme for Conformity Assessment  
ASCA: Accreditation Scheme for Conformity Assessment Expert: Mario Klessascheck ASCA stands for Accreditation Scheme for Conformity Assessment. The procedure is intended to accelerate conformity  
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PMS trend analysis - a complex issue where you cannot fail  
Trend analysis is a legal requirement for medical device manufacturers, especially for "Post-Market Surveillance." Here are the instructions.  
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DIN EN IEC 80001-1:2023  
DIN EN IEC 80001-1:2023 IEC 80001-1 has the long title "Application of risk management for IT-networks containing medical devices - Part 1: Tasks, responsibilities and activities". This article r  
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