Biologic compatibility of medical devices

Biocompatibility - Part 1

What is biocompatibility and how do you prove it? Here we explain the topic from the beginning.

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Anleitung zur klinischen Bewertung von Medizinprodukten

Clinical Evaluation - Part 1

Preparation for the compilation of a clinical evaluation.

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Fundamentals for creating clinical evaluations under the MDR.

Clinical Evaluation - Part 2

Fundamentals, tools and usable data

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FDA registrations for medical devices - part 1

FDA registrations - Part 1

How to bring your medical devices legally into the U.S. market?

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In-vitro-Diagnostika in der Medizintechnik

In-vitro-Diagnostics - Part 1

IVDs are an important but relatively unknown part of medical technology. But why?

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Performance evaluation of IVDs according to IVDR (EU)2017/746

IVD Performance Evaluation - Part 1

We introduce you into the performance evaluation according to the IVDR!

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MDSAP - Medical Device Single Audit Program

MDSAP - Part 1

All you need to know about the Medical Device Single Audit Program!

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PMCF post-market clinical follow-up for medical devices under MDR

PMCF Post-market Clinical Follow-Up

What is PMCF and how can this facilitate the MDR transition?

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Post-market surveillance fundamentals - betterblog.

Post-market surveillance - Part 1

What is post-market surveillance and how does it work? - Basics of PMS.

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Post-market surveillance fundamentals - betterblog.

Post-market surveillance - Part 2

Post-market surveillance, medical devices and the responsibility of the manufacturer.

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Quality Management in medical devices and IVDs.

Quality Management - Part 1

Introduction to the topic "QM" and why it is so important.

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Risk Management for medical devices and IVDs

Risk Management - Part 1

Basics of risk management for medical devices and IVDs.

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Risk Management for medical devices and IVDs

Risk Management - Part 2

In a nutshell: Risk management for medical devices


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Usability of medical devices and IVDs

Usability - Part 1

What does usability mean for medical devices and IVDs?

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Vigilance in the medical device industry. Reporting of serious incidents - Part 1

Vigilance - Part 1

What is vigilance in medical technology? In this article we explain the basics.

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