Blog – Medicaldeviceguide

Navigating Technical Documentation: Your Guide to Understanding In Vitro Diagnostic Medical Device Specifications

20 April, 2024 medicaldeviceguide 0 Comments

Device Description (a) Product or Trade Name and General Description: Begin by introducing the device, including its name and a brief overview of its purpose. Consider highlighting its key features and functionalities to provide context…

Definition Involved in In Vitro Diagnostic Medical Device

19 April, 2024 medicaldeviceguide 0 Comments

1. In Vitro Diagnostic Medical Device Imagine you're at the doctor's office and they need to run some tests to understand what's going on inside your body. They might use various tools and equipment to…

“Unveiling the IVDR: Your Guide to Understanding In Vitro Diagnostic Device Risks”

18 April, 2024 medicaldeviceguide 0 Comments

Introduction: "Step into the fascinating world of in vitro diagnostic devices, where every test holds the promise of unlocking vital health insights. But amidst this realm of innovation lies a crucial factor often overlooked—risk. Join…

Understanding the EU Declaration of Conformity: Ensuring Safety and Quality

15 March, 2024 medicaldeviceguide 0 Comments

Introduction In today's interconnected world, where products travel across borders and oceans, ensuring their safety and conformity to regulations is paramount. One crucial document that stands as a testament to a manufacturer's commitment to quality…

Steps towards compliance with EN 60601

28 February, 2024 medicaldeviceguide 0 Comments

Achieving EN 60601 compliance involves several steps to ensure that your medical electrical equipment meets the safety and essential performance requirements specified by the standards. Below are the main steps towards compliance: Familiarize yourself with EN…

Navigating Technical Documentation: Your Guide to Understanding In Vitro Diagnostic Medical Device Specifications

Definition Involved in In Vitro Diagnostic Medical Device

“Unveiling the IVDR: Your Guide to Understanding In Vitro Diagnostic Device Risks”

Understanding the EU Declaration of Conformity: Ensuring Safety and Quality

Steps towards compliance with EN 60601

Regulation of Medical Devices and In Vitro Diagnostic Medical Devices in Northern Ireland

Embracing sustainability and the circular economy in the medical device industry: Understanding the differences

FDA and ISO 13485 – Cause for Concern or Celebration?

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