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Medical devices
Medical devices
IVD
Planning and reporting according to IVDR 2017/746 from Class A to
Class D.

Performance Evaluation
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Efficient continuous process of post-market surveillance for IVDs and medical devices.

Post-market surveillance
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Consulting
Discuss your regulatory (MDD / MDR), developmental or strategic questions with our experts.
Ad-hoc solutions
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Technical documentation
Clinical Evaluation
Biological Evaluation
SSCP
Post-market surveillance
Development
Publication writing
Literature search
Expert statement
Study design
Toxicology
Toxicological assessment
Occupational health
Environmental risk assessment
All medical device services
Digital health
DiGA
Software as a medical device
PFAS in medical devices
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Imprint
Pharma
Writing
Regulatory documentation
eCTD compilation
Target Safety Assessment
Investigator's brochure
IMPD
Toxicology services
Toxicological assessments
Permissible daily exposure
Health-based exposure limit
Acceptable intake (ADI / TDI)
Environmental risk assessment
Expert services
Do we really need a study? If so, how should our study look like, what are the best endpoints and where should we conduct it?
Study design & strategy
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Professional literature searches by expert medical writers on new technologies, indications, targets, and more.
Literature search
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Consulting
Receive 2nd opinions from industry veterans and gain confidence on strategic and scientific decisions.
Ad-hoc solutions
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Imprint
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Expert statement
About us
The company
Consultancy & software development
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ANZEIGEN
Sustainabilty
Actually acting
Get inspired

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Leadership
Introducing company management
I'm curious

ANZEIGEN
In vitro diagnostics
Performance evaluation plan & report
Post-market surveillance
Expert services
Literature searches
Publication writing
Consulting
Drug-device combinations
Drug-device combination
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Imprint
News
News section
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