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Liaison with Notified Bodies

Liaison with Notified Bodies

Our Experts will ensure complete Communication with the Competent Authority

19.1.2023

Notified Body and Engagement

Notified Body and Engagement

Let the experts talk on your behalf!

19.1.2023

PRRC Person Responsible for Regulatory Compliance

PRRC Person Responsible for Regulatory Compliance

Keeping up with the latest regulations and standards can be a daunting task That's where outsourcing the role of PRRC comes in

16.1.2023

Attack on Your Device!

Attack on Your Device!

Cyber Threats and Security have become the most discussed topics.

10.1.2023

Cyber Attack on Digital Health

Cyber Attack on Digital Health

Read about the attack on connected health devices.

10.1.2023

MedTech Companies – Stay Alert!

MedTech Companies – Stay Alert!

Protect your MedTech from cyber-attacks. Make them CYBER SAFE

10.1.2023

Different types of ISO 13485 Audits

Different types of ISO 13485 Audits

Audits are a key component of ISO 13485:2016

30.11.2022

EURLs IVDR

EURLs IVDR

What are EU Reference Laboratories under IVDR? EURLs

9.11.2022

Protect Your ISO 13485:2016 Quality Management System – Mistakes to Avoid

Protect Your ISO 13485:2016 Quality Management System – Mistakes to Avoid

ISO 13485:2016 – your partial gateway towards market entry around the World!

24.10.2022

Medical Technology Ireland 2022

Medical Technology Ireland 2022

Read About the Economic Operators under MDR, IVDR in the EU!

22.9.2022

Risk Management Analysis (ISO 14971:2019)

Risk Management Analysis (ISO 14971:2019)

Medical Device Manufacturers have a legal obligation to regularly maintain and perform risk management analyses.

15.7.2022

Patient information management (IFU, Labelling and Cartons)

Patient information management (IFU, Labelling and Cartons)

A ‘Label’ is the identity of the product.

15.7.2022

Unique Device Identification (UDI) & Global Unique Device Identification Database (GUDID)

Unique Device Identification (UDI) & Global Unique Device Identification Database (GUDID)

It allows the identification of specific devices on the market and facilitates their traceability.

15.7.2022

What is CircaBC?

What is CircaBC?

The easiest way to share information in the European Commission

14.7.2022

Manufacturers' guide to IVDR Update related to EUDAMED

Manufacturers' guide to IVDR Update related to EUDAMED

MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions

14.7.2022

Design Control (verification & validation)

Design Control (verification & validation)

For the end user's safety and to place the Medical Innovation on the market, a manufacturer has a legal obligation to maintain design control files.

12.7.2022

Design File Compilation

Design File Compilation

Understanding the Design File and the process of compilation.

12.7.2022

General Safety and Performance Requirements (GSPRs) checklist

General Safety and Performance Requirements (GSPRs) checklist

Meaning of General Safety and Performance Requirements (GSPRs) and the checklist.

12.7.2022

What is EUDAMED

What is EUDAMED

EU-DA-MED
European Database on Medical Devices

7.7.2022

Who is required to submit a 510(k)?

Who is required to submit a 510(k)?

The regulations do not specify who must submit a 510(k) but they specify which actions require a 510(k) submission

9.6.2022

Substantial Equivalence in 510(k)

Substantial Equivalence in 510(k)

Read and understand about Substantial Equivalence to protect your application.

7.6.2022

510k Process Guide

510k Process Guide

Are you launching your device in the USA? Find out more about 510(k) requirements.

1.6.2022

Basics of EU Authorised Representative

Basics of EU Authorised Representative

Let's find out more information about EU Authorised Representative!

20.5.2022

IVDR Celebration Week - Opening Ceremony

IVDR Celebration Week - Opening Ceremony

Details of the Opening Ceremony!

21.4.2022

IVDR Celebration Week Session 1

IVDR Celebration Week Session 1

Details of Session 1 - Overview of IVDR

21.4.2022

IVDR Celebration Week Session 2

IVDR Celebration Week Session 2

Details on Session 2 - IVDR and the Clinical Requirements for IVD Manufacturers in Europe

21.4.2022

IVDR Celebration Week Session 3

IVDR Celebration Week Session 3

Details on Session 3 - IVD Medical Device - Understanding SaMD and Cyber Security Requirements

21.4.2022

IVDR Celebration Week Session 4

IVDR Celebration Week Session 4

Details on Session 4 - IVD Medical Device - the need for UDI and Barcodes

21.4.2022

IVDR Celebration Week Session 5

IVDR Celebration Week Session 5

Details on Session 5 - What is a clinical performance study, and why do you need it?

21.4.2022

IVDR Celebration Week Session 6

IVDR Celebration Week Session 6

Details on Session 6 - Where to Start in order to launch an IVD Medical Device onto the EU Market

21.4.2022

IVDR Celebration Week Closing Ceremony

IVDR Celebration Week Closing Ceremony

Details on Closing Ceremony

21.4.2022

MedTech Trend of the Future!

MedTech Trend of the Future!

Read about the elements of MedTech making their way to the future!

21.3.2022

Navigating MedTech regulations in the era of digital revolution

Navigating MedTech regulations in the era of digital revolution

Insights to Impact Masterclass: Navigating MedTech regulations in the era of digital revolution
Mar 17, 2022

23.2.2022

FAQS: In-Vitro Diagnostic Medical Device Regulation (IVDR)

FAQS: In-Vitro Diagnostic Medical Device Regulation (IVDR)

7 top tips for understanding IVDR! Update yourself as we answer your queries regarding In-Vitro Diagnostic Medical Device Regulation (IVDR).

15.2.2022

IVDR MasterClass

IVDR MasterClass

Med-Di-Dia, GRS and EIT Health brings to you a Masterclass on upcoming IVDR Regulations

9.2.2022

Alessia Shares Her Story

Alessia Shares Her Story

Pandemics - Present and Future! A look into the event

9.2.2022

Protecting your medical devices from ransomware

Protecting your medical devices from ransomware

Cyber threats are increasing every day. Read about protecting your Medical Device.

1.2.2022

MedTech and Ethical Artificial Intelligence

MedTech and Ethical Artificial Intelligence

With advancements in MedTech, it is now time for ethics and principles.

11.1.2022

Medical Device Registration Strategies

Medical Device Registration Strategies

Suggested strategies for Registering your Medical Device. Read Now!

22.12.2021

Medical Device and the Need for Security

Medical Device and the Need for Security

Medical Devices need a 360° protection against various threats. Read How…

14.12.2021

Oh, MDR! Look, what have you done? Part 2

Oh, MDR! Look, what have you done? Part 2

MDR has rocked the regulatory world. Let’s take a look.

9.12.2021

MedTech and the Internet of Medical Things

MedTech and the Internet of Medical Things

A blockbuster session where you will get insights straight from those already ‘in the know’ including Visionary Innovators, Specialists in Regulatory.

3.12.2021

Medical Technology Ireland Round Up

Medical Technology Ireland Round Up

Team Med-Di-Dia visited Medical Technology Ireland. Read our Story!

19.11.2021

Ida's Visit to Medical Technology Ireland

Ida's Visit to Medical Technology Ireland

Ida Marvataj, our BD team member shares her experience of Medical Technology Ireland.

16.11.2021

Alfredo's Day 1 at Medical Technology Ireland

Alfredo's Day 1 at Medical Technology Ireland

What does our BD team think about Medical Technology Ireland? Read Now!

11.11.2021

Marie Gallagher at Medical Technology Conference

Marie Gallagher at Medical Technology Conference

A snapshot and quick learning from Marie Gallagher's Conference Presentation.

9.11.2021

Oh, MDR! Look, what have you done? Part 1

Oh, MDR! Look, what have you done? Part 1

MDR has rocked the regulatory world. Let’s take a look.

5.11.2021

Responsibilities of EU AR

Responsibilities of EU AR

Here are the top 7 responsibilities of an EU AR

2.11.2021

Clinical Investigation Ecosystem

Clinical Investigation Ecosystem

MDR emphasizes Clinical Investigation for class III devices. Read how to navigate

21.9.2021

Clinical Evaluation V/S Investigation

Clinical Evaluation V/S Investigation

Get clarity on different clinical aspects for your medical device.

16.9.2021

Sources of Clinical Data

Sources of Clinical Data

Do you need a clinical evaluation? Worried about collecting clinical data? Read our guide

13.9.2021

Clinical Evaluation Plan

Clinical Evaluation Plan

Understand the meaning and requirements of the clinical evaluation. Read More…

6.9.2021

Challenges involved in clinical evaluations

Challenges involved in clinical evaluations

Clinical Evaluations come with great risks. Read more

2.9.2021

Guide for Clinical Evaluation reporting

Guide for Clinical Evaluation reporting

Read more about the clinical evaluation reporting process.

26.8.2021

Factors to keep in mind preparing for Clinical Evaluation.

Factors to keep in mind preparing for Clinical Evaluation.

Clinical Evaluation, a process that can challenge your innovation. Read More

19.8.2021

Clinical Evaluations

Clinical Evaluations

Read more about Clinical Evaluations and factors associated with them.

12.8.2021

What is a Clinical Evaluation?

What is a Clinical Evaluation?

Understand the meaning of Clinical Evaluations. Read our Expert Guide!

5.8.2021

Notified Bodies in EU MDR 

Notified Bodies in EU MDR 

Easy to understand blog on Notified Bodies… Read More

22.7.2021

One month from the application of the EU MDR – Let’s Revisit and Reflect!

One month from the application of the EU MDR – Let’s Revisit and Reflect!

Over the last decade, Medical Regulations and compliance have had a significant impact on the medical device industry.

29.6.2021

Where to start with developing a Medical Device Regulatory Strategy?

Where to start with developing a Medical Device Regulatory Strategy?

Developing an efficient regulatory strategy is a challenging task requiring in-depth knowledge and a thorough understanding of regulatory requirements

26.6.2021

Aspects of Regulatory Strategy

Aspects of Regulatory Strategy

A regulatory strategy comprises 3 essential elements, Device Classification, Compliance Requirements and Compliance Ownership.

24.6.2021

Can the regulatory strategy define medical device marketing strategy?

Can the regulatory strategy define medical device marketing strategy?

Regulations and Marketing are interdependent with regulation being the beacon light. Find out more.

20.6.2021

Understanding the meaning of Medical Device and Medical Device Regulatory Strategy

Understanding the meaning of Medical Device and Medical Device Regulatory Strategy

Medical Devices are defined differently in different parts of the world. Read more to understand the right classification.

18.6.2021

Define your product and develop your regulatory strategy

Define your product and develop your regulatory strategy

In the following series, Med-Di-Dia will help you create a strategy for entering the US and EU medical device markets.

16.6.2021

Who Can Sell in the USA and the EU Medical Device Markets?

Who Can Sell in the USA and the EU Medical Device Markets?

Establishing the Target Market is a key step towards developing your regulatory strategy. Read about the USA and the EU medical device sales process.

14.6.2021

How to prepare your medical device company for an US FDA inspection

How to prepare your medical device company for an US FDA inspection

FDA visits are common and can even be unannounced! Read this guide to stay up-to-date and avoid ‘tripping up’ when the FDA comes knocking on your door

9.6.2021

Mandatory UDI Deadlines for Medical Devices

Mandatory UDI Deadlines for Medical Devices

UDI Compliance and its mandatory timelines. 

3.6.2021

Affixing a CE Mark

Affixing a CE Mark

If you have obtained approval or completed a Declaration of Conformity (DoC), here is a guide on affixing the CE Mark.

31.5.2021

Medical Devices - UDI

Medical Devices - UDI

UDIs will play an important role in traceability and increasing the efficiency of post-market safety activities. Getting UDI for a Medical Device is a

29.5.2021

What is SaMD – How will it be Regulated?

What is SaMD – How will it be Regulated?

With introduction of EU MDR what is SaMD and key updates on regulations of SaMD

26.5.2021

Guide for obtaining a CE Mark

Guide for obtaining a CE Mark

A CE mark logo is an essential identification for medical devices of a certain class. Read about the process to obtain CE Mark.

24.5.2021

Top 3 Changes in the EU MDR

Top 3 Changes in the EU MDR

From 26th May 2021 the new EU Medical Device Regulation (MDR) will be in full force. Tackle the changes coming in with Med-Di-Dia

20.5.2021

The role of EU PRRC

The role of EU PRRC

MDR increases the complexity by introducing the need of a PRRC

19.5.2021