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Navigating the New Frontier: FDA's Draft Guidance on AI-Enabled Device Software Functions

Navigating the New Frontier: FDA's Draft Guidance on AI-Enabled Device Software Functions

7/1/2025

The FDA's recent draft guidance on AI-Enabled Device Software Functions outlines critical lifecycle management and marketing submission recommendations that could redefine how medical devices are...
Get Ready for the GPSR Deadline!

Get Ready for the GPSR Deadline!

5/12/2024

The General Product Safety Regulation (GPSR) comes into effect on 13 December 2024, bringing new responsibilities for manufacturers, distributors, and online marketplaces selling in the EU.
Med-Di-Dia Expands Services: Introducing EU Responsible Person Support for GPSR Compliance

Med-Di-Dia Expands Services: Introducing EU Responsible Person Support for GPSR Compliance

29/11/2024

We are excited to announce that Med-Di-Dia has expanded its service offerings to include the role of EU Responsible Person, helping non-EU manufacturers comply with the General Product Safety Regulati...
Black Friday & Cyber Monday Exclusive: Free Strategy Call for Digital Health Innovators – Appoint Med-Di-Dia as Your Regulatory Risk Partner!

Black Friday & Cyber Monday Exclusive: Free Strategy Call for Digital Health Innovators – Appoint Med-Di-Dia as Your Regulatory Risk Partner!

25/11/2024

Navigating the fine line between wellness devices and medical devices can feel overwhelming. Whether you're working on Software as a Medical Device (SaMD) or Artificial Intelligence as a Medical ...
Irish Health institutions that manufacture and use in-house IVDs are now required to notify HPRA of their activities.

Irish Health institutions that manufacture and use in-house IVDs are now required to notify HPRA of their activities.

28/10/2024

This notification process ensures that the health institution complies with national and EU regulations.
Service Overview for In-House Manufacturers of Medical Devices and In Vitro Diagnostic Medical Devices

Service Overview for In-House Manufacturers of Medical Devices and In Vitro Diagnostic Medical Devices

22/10/2024

With our deep expertise in EU regulations and compliance, we ensure that your institution meets all the legal requirements while streamlining the notification process with the Health Products Regulato...
AI-Driven Medical Device Regulatory Compliance: New Article by Dr. Shahram Ahmadi Published in RAPS RF Quarterly

AI-Driven Medical Device Regulatory Compliance: New Article by Dr. Shahram Ahmadi Published in RAPS RF Quarterly

24/9/2024

Dr. Ahmadi’s article delves into the evolving regulatory landscape and outlines how global regulatory bodies are adapting to the rise of AI/ML-enabled medical devices.
World Patient Safety Day 2024: "Get it Right, Make it Safe!"

World Patient Safety Day 2024: "Get it Right, Make it Safe!"

16/9/2024

Get it Right, Make it Safe!
MDCG 2021-5 Rev. 1: A Closer Look at Standardisation for Medical Devices

MDCG 2021-5 Rev. 1: A Closer Look at Standardisation for Medical Devices

2/7/2024

New Updates in MDCG 2021-5 Rev. 1: A Closer Look at Standardisation for Medical Devices
Med Tech Innovation Expo 2024 Birmingham and Med-Di-Dia

Med Tech Innovation Expo 2024 Birmingham and Med-Di-Dia

24/5/2024

Med-Di-Dia has taken a step further and collaborated with several partners to maximise the advantages of this gathering.
Join Us at the MedTech Innovation Expo and Conference!

Join Us at the MedTech Innovation Expo and Conference!

24/5/2024

We at Med-Di-Dia are thrilled to announce a pioneering event coming your way.
IVDR Amendment

IVDR Amendment

25/4/2024

The European Parliament voted in favour of the European Commission’s proposal.
MDCG 2024-4 Safety Reporting in Performance Studies of IVDs under IVDR

MDCG 2024-4 Safety Reporting in Performance Studies of IVDs under IVDR

17/4/2024

This guidance outlines the procedures for safety reporting in performance studies in the absence of the Eudamed module or when Eudamed is not yet fully functional.
MDCG 2022 – 9 Rev. 1

MDCG 2022 – 9 Rev. 1

15/4/2024

Summary of safety and performance Template
Support for QMSR

Support for QMSR

3/4/2024

Save the Date: Thursday, May 23rd, 1pm to 2pm Irish Time
Med-Di-Dia x Digital Health Copenhagen

Med-Di-Dia x Digital Health Copenhagen

2/4/2024

Dr Shahram Ahmadi, will join the panel hosted by Digital Health Copenhagen.
Ambitious Essex Innovation Accelerator and Med-Di-Dia

Ambitious Essex Innovation Accelerator and Med-Di-Dia

27/3/2024

Eliminating Regulatory Risk! One step at a time.
Commission proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply

Commission proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply

8/3/2024

Med-Di-Dia and Global Regulatory Services (GRS) are thrilled to announce a fireside chat-style LinkedIn Live session
Proposed extension of Transitional Timelines for IVDR

Proposed extension of Transitional Timelines for IVDR

8/3/2024

Commission proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply.
January 2024 Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

January 2024 Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

15/2/2024

The document provides a timeline and a status for each priority action, as well as the actors involved in their implementation. It also serves as a living document to monitor the progress of the work ...

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