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366 results:
In Vitro Diagnostic Medical Device Performance Evaluation: 8 Steps to Conformity  
In Vitro Diagnostic Medical Device Performance Evaluation: 8 Steps to Conformity Tuesday, May 5, 2020 If manufacturers don’t conduct a legally compliant performance evaluation of their in vi  
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Process FMEA (pFMEA): How to Systematically Identify Process Risks  
The process FMEA (pFMEA) is a method for the systematic analysis of risks resulting from failure modes in processes, such as device production and cleaning. Laws, such as the MDR, and standards, such  
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Planning Sample Sizes for Clinical Studies of Medical Devices and IVDs: The 6 Questions Your Statistician Must Answer  
Planning Sample Sizes for Clinical Studies of Medical Devices and IVDs: The 6 Questions Your Statistician Must Answer If you have to conduct a clinical investigation for your medical device or clin  
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IVD Admission Strategy  
Pending new approval for your invitro diagnostic medical device (IVD) Are you sure your approval strategy will get you through the audit in 2022? Many IVD manufacturers are not aware of the actual  
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Medical Devices as Disability Aids: An Additional Source of Revenue?  
Medical Devices as Disability Aids: An Additional Source of Revenue? Health insurance funds reimburse insured people for disability aids, and because disability aids are often also medical devices,  
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Management Reviews: 5 Reasons Why Bosses Should Love Them  
Management Reviews: 5 Reasons Why Bosses Should Love Them It doesn't matter whether you call it the management review, management evaluation, or the QM evaluation because these terms are synonymous  
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ISO 20417:2021 – Finally Some Clear Requirements for Accompanying Information  
ISO 20417:2021 – Finally Some Clear Requirements for Accompanying Information ISO 20417:2021 Medical devices – Information to be supplied by the manufacturer establishes requirements for the genera  
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IOP Governance-Verordnung (GIGV) - What Manufacturers Can Expect  
IOP Governance-Verordnung (GIGV) - What Manufacturers Can Expect The new Gesundheits-IT-Interoperabilitäts-Governance-Verordnung or (IOP Governance-Verordnung, GIGV for short) will come into force  
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International Medical Device Authorizations: 5 Steps to New Markets  
International Medical Device Authorizations: 5 Steps to New Markets A lot of medical device manufacturers see the international authorization of their device as a potential hazard: the opportunitie  
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INMETRO and ANATEL Certification: Requirements for Authorization in Brazil?  
INMETRO and ANATEL Certification: Requirements for Authorization in Brazil? If ANVISA registration is no longer enough As a manufacturer, there are some hurdles you have to clear before selling y  
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