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Biocompatibility

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

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Clinical Evaluation - Part 1

Preparation for the compilation of a clinical evaluation.

Clinical Evaluation - Part 2

Fundamentals, tools and usable data

FDA registrations

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

In-vitro-Diagnostics

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

IVD Performance Evaluation - Part 1

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

IVD Performance Evaluation - Part 2

Preparation of a performance evaluation.

MDSAP

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

PMCF Post-market Clinical Follow-Up

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

Post-market surveillance - Part 1

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

Quality Management

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

Risk Management - Part 1

Basics of risk management for medical devices and IVDs.

Risk Management - Part 2

In a nutshell: Risk management for medical devices

Usability

What does usability mean for medical devices and IVDs?

Vigilance

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