Celebrating Three Decades of Excellence: Platform94’s Inspiring Journey from GTC
As Platform94 celebrates an impressive 30 years of service, we are honoured to reflect on their remarkable transformation.
18.11.2024
Internationalising MedTech Innovation
Don’t miss this chance to gain critical insights from industry experts with decades of experience navigating the complexities of MedTech international
11.11.2024
Understanding the Certificate of Free Sale in the EU: A Comprehensive Guide
A Certificate of Free Sale (CFS) is an essential document for manufacturers & authorised representatives looking to export medical devices outside EU
23.10.2024
Here’s a breakdown of the certificates from each region and factors to consider for the first market entry.
2.10.2024
Understanding Device Classification and Predicate Device Searches in the US
Launching a medical device in the United States requires navigating a complex regulatory environment governed by the U.S. Food and Drug Administration
13.8.2024
Sterilisation Validation Reports for Medical Devices
Sterilisation validation ensures that products are safe for patient use by eliminating all forms of microbial life.
9.8.2024
Steps in Launching a Medical Device in the USA: A 10-step guide
Is it really a 10 step process?
29.7.2024
Investigator’s Brochure (IB) for Medical Devices
Sponsors are encouraged to review the full details of the MDR and the ISO 14155:2020 standard when preparing the IB.
18.7.2024
Secrets of MedTech Supply Chain Compliance
Unlock the Secrets of MedTech Supply Chain Compliance: Download Our Exclusive White Paper!
26.6.2024
How to assign Master UDI-DIs to contact lenses: A new regulation update
The European Commission on 20 October 2023 published an amendment which introduces a new concept of Master UDI-DI for contact lenses.
26.3.2024
On 6th December 2023, the USFDA announced the voluntary use of eSTAR - Electronic Submission Template.
29.2.2024
eSTAR: A New Way to Submit 510(k) Submissions Electronically
If you are a medical device manufacturer who plans to submit a premarket notification (510(k)) to the FDA, you may want to know about eSTAR
21.2.2024
AI-Airlock: MHRA’s new way to test and regulate AI in healthcare
AI is transforming the healthcare sector in many ways, from improving diagnosis and treatment to providing personalised care and support.
1.2.2024
CE Mark extension is NOT Automatic
The EU MDR extension for certain medical devices only allows you up until 31st December 2027 or 2028 if you have a signed contract..
29.1.2024
Understanding Serious Injuries Caused by Medical Devices: What Happens Next?
Prioritise patient safety with these steps!
27.10.2023
Pre-market Submissions for Device Software Functions
MedTech is not just about a medical device with capabilities!
11.8.2023
IVDR Documentation Submission – Best Practices
IVDR Documentation Submission Best Practice Guidelines
4.8.2023
AI and Cybersecurity for Medical Imaging Diagnosis.
Protect your medical solutions from the threats and vulnerabilities of AI!
30.6.2023
Tips for Unbiased Medical Device Product Design
Let your innovation be Bias-Free. Read Now...
25.4.2023
Selecting a Medical Device Supplier
A guide on how to select a supplier for your medical device.
21.4.2023
Medical Device Regulation in the EU
Team NB Position Paper on Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of EU MDR
19.4.2023
Q&A related to TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS
31.3.2023
Operating without an EU Entity?
You could be at risk of a Product recall, Penalty or legal action!
6.3.2023
When it comes to medical device manufacturing, patient safety depends on the quality and consistency of medical products.
2.3.2023
Our Experts will ensure complete Communication with the Competent Authority
19.1.2023
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
MedTech Companies – Stay Alert!
Protect your MedTech from cyber-attacks. Make them CYBER SAFE
10.1.2023
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
Read About the Economic Operators under MDR, IVDR in the EU!
22.9.2022
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)
A ‘Label’ is the identity of the product.
15.7.2022
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
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)
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
General Safety and Performance Requirements (GSPRs) checklist
Meaning of General Safety and Performance Requirements (GSPRs) and the checklist.
12.7.2022
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)
Read and understand about Substantial Equivalence to protect your application.
7.6.2022
Are you launching your device in the USA? Find out more about 510(k) requirements.
1.6.2022
Basics of EU Authorised Representative
Let's find out more information about EU Authorised Representative!
20.5.2022
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
Details on Session 3 - IVD Medical Device - Understanding SaMD and Cyber Security Requirements
21.4.2022
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
Details on Session 5 - What is a clinical performance study, and why do you need it?
21.4.2022
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
Read about the elements of MedTech making their way to the future!
21.3.2022
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)
7 top tips for understanding IVDR! Update yourself as we answer your queries regarding In-Vitro Diagnostic Medical Device Regulation (IVDR).
15.2.2022
Med-Di-Dia, GRS and EIT Health brings to you a Masterclass on upcoming IVDR Regulations
9.2.2022
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
With advancements in MedTech, it is now time for ethics and principles.
11.1.2022
Medical Device Registration Strategies
Suggested strategies for Registering your Medical Device. Read Now!
22.12.2021
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
MDR has rocked the regulatory world. Let’s take a look.
9.12.2021
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
Team Med-Di-Dia visited Medical Technology Ireland. Read our Story!
19.11.2021
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
What does our BD team think about Medical Technology Ireland? Read Now!
11.11.2021
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
MDR has rocked the regulatory world. Let’s take a look.
5.11.2021
Clinical Investigation Ecosystem
MDR emphasizes Clinical Investigation for class III devices. Read how to navigate
21.9.2021
Clinical Evaluation V/S Investigation
Get clarity on different clinical aspects for your medical device.
16.9.2021
Do you need a clinical evaluation? Worried about collecting clinical data? Read our guide
13.9.2021
Understand the meaning and requirements of the clinical evaluation. Read More…
6.9.2021
Challenges involved in clinical evaluations
Clinical Evaluations come with great risks. Read more
2.9.2021
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.
Clinical Evaluation, a process that can challenge your innovation. Read More
19.8.2021
Read more about Clinical Evaluations and factors associated with them.
12.8.2021
What is a Clinical Evaluation?
Understand the meaning of Clinical Evaluations. Read our Expert Guide!
5.8.2021
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?
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
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?
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
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
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?
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
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
If you have obtained approval or completed a Declaration of Conformity (DoC), here is a guide on affixing the CE Mark.
31.5.2021
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
With introduction of EU MDR what is SaMD and key updates on regulations of SaMD
26.5.2021
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
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
