Our Experts will ensure complete Communication with the Competent Authority
Let the experts talk on your behalf!
Keeping up with the latest regulations and standards can be a daunting task That's where outsourcing the role of PRRC comes in
Cyber Threats and Security have become the most discussed topics.
Read about the attack on connected health devices.
Protect your MedTech from cyber-attacks. Make them CYBER SAFE
Audits are a key component of ISO 13485:2016
What are EU Reference Laboratories under IVDR? EURLs
ISO 13485:2016 – your partial gateway towards market entry around the World!
Read About the Economic Operators under MDR, IVDR in the EU!
Medical Device Manufacturers have a legal obligation to regularly maintain and perform risk management analyses.
A ‘Label’ is the identity of the product.
It allows the identification of specific devices on the market and facilitates their traceability.
The easiest way to share information in the European Commission
MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions
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.
Understanding the Design File and the process of compilation.
Meaning of General Safety and Performance Requirements (GSPRs) and the checklist.
European Database on Medical Devices
The regulations do not specify who must submit a 510(k) but they specify which actions require a 510(k) submission
Read and understand about Substantial Equivalence to protect your application.
Are you launching your device in the USA? Find out more about 510(k) requirements.
Let's find out more information about EU Authorised Representative!
Details of the Opening Ceremony!
Details of Session 1 - Overview of IVDR
Details on Session 2 - IVDR and the Clinical Requirements for IVD Manufacturers in Europe
Details on Session 3 - IVD Medical Device - Understanding SaMD and Cyber Security Requirements
Details on Session 4 - IVD Medical Device - the need for UDI and Barcodes
Details on Session 5 - What is a clinical performance study, and why do you need it?
Details on Session 6 - Where to Start in order to launch an IVD Medical Device onto the EU Market
Details on Closing Ceremony
Read about the elements of MedTech making their way to the future!
Insights to Impact Masterclass: Navigating MedTech regulations in the era of digital revolution
Mar 17, 2022
7 top tips for understanding IVDR! Update yourself as we answer your queries regarding In-Vitro Diagnostic Medical Device Regulation (IVDR).
Med-Di-Dia, GRS and EIT Health brings to you a Masterclass on upcoming IVDR Regulations
Pandemics - Present and Future! A look into the event
Cyber threats are increasing every day. Read about protecting your Medical Device.
With advancements in MedTech, it is now time for ethics and principles.
Suggested strategies for Registering your Medical Device. Read Now!
Medical Devices need a 360° protection against various threats. Read How…
MDR has rocked the regulatory world. Let’s take a look.
A blockbuster session where you will get insights straight from those already ‘in the know’ including Visionary Innovators, Specialists in Regulatory.
Team Med-Di-Dia visited Medical Technology Ireland. Read our Story!
Ida Marvataj, our BD team member shares her experience of Medical Technology Ireland.
What does our BD team think about Medical Technology Ireland? Read Now!
A snapshot and quick learning from Marie Gallagher's Conference Presentation.
MDR has rocked the regulatory world. Let’s take a look.
Here are the top 7 responsibilities of an EU AR
MDR emphasizes Clinical Investigation for class III devices. Read how to navigate
Get clarity on different clinical aspects for your medical device.
Do you need a clinical evaluation? Worried about collecting clinical data? Read our guide
Understand the meaning and requirements of the clinical evaluation. Read More…
Clinical Evaluations come with great risks. Read more
Read more about the clinical evaluation reporting process.
Clinical Evaluation, a process that can challenge your innovation. Read More
Read more about Clinical Evaluations and factors associated with them.
Understand the meaning of Clinical Evaluations. Read our Expert Guide!
Easy to understand blog on Notified Bodies… Read More
Over the last decade, Medical Regulations and compliance have had a significant impact on the medical device industry.
Developing an efficient regulatory strategy is a challenging task requiring in-depth knowledge and a thorough understanding of regulatory requirements
A regulatory strategy comprises 3 essential elements, Device Classification, Compliance Requirements and Compliance Ownership.
Regulations and Marketing are interdependent with regulation being the beacon light. Find out more.
Medical Devices are defined differently in different parts of the world. Read more to understand the right classification.
In the following series, Med-Di-Dia will help you create a strategy for entering the US and 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.
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
UDI Compliance and its mandatory timelines.
If you have obtained approval or completed a Declaration of Conformity (DoC), here is a guide on affixing the CE Mark.
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
With introduction of EU MDR what is SaMD and key updates on regulations of SaMD
A CE mark logo is an essential identification for medical devices of a certain class. Read about the process to obtain CE Mark.
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
MDR increases the complexity by introducing the need of a PRRC