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Med-Di-Dia and Thomas Regulatory Resolutions are using the social media platform to spread awareness about medical device regulatory affairs.

17/6/2021

Using the advantage of the digital space, bustling medical device regulatory service providers are going LinkedIn Live!

The future of Wearable Devices.

15/6/2021

With advancing technology and MedTech Innovations, the future brings challenges as well as opportunities for wearable devices.

Cambridge Academy of Therapeutic Sciences announces seminar with Med-Di-Dia.

9/6/2021

It is crucial to ensure that you are constantly updated in the dynamic and ever-developing medical world. Therefore, organisers at the Cambridge Academy of Therapeutic Sciences have initiated a semina...

EU MDR - what’s happening with Switzerland?

8/6/2021

Before 26th May 2021, medical devices had restriction-free movement between Switzerland and the EU market. Since MDR was fully implemented throughout Europe from 26th May 2021, and with the breakdown ...

MedTech Europe warns of ongoing regulatory issues

3/6/2021

MedTech Europe welcomed the first wave of new E.U. medical device regulations last week but said there’s work that’s yet to be done.

Med-Di-Dia Team Expansion

1/6/2021

Welcoming the new set of Professionals. Med-Di-Dia Team is expanding. We aim at creating strong regulatory support for our Clients.

The US FDA releases draft guidelines for Medical Devices

27/5/2021

The US FDA released draft guidelines for neurostim, other devices to treat diabetes and guidance for Testing and Labelling Medical Devices for Safety in the Magnetic Resonance (MR) Environment

EU plans to enforce additional regulations on MedTech AI products, other 'high-risk' systems.

25/5/2021

AI and SaMD are the future of MedTech development. In these times, such stringent regulations could be seen to hamper the industry's capacity to innovate.

Report from Deloitte Spotlights the Trend for Virtual Care

20/5/2021

Virtual care in the pre-pandemic era was considered a slow-moving industry. Investors have heavily invested their stakes in virtual health and care management technology.

Main changes introduced by the MDR for Class I Device Manufacturers

18/5/2021

All medical device companies will be affected by new developments under MDR, which comes into effect on 26th May 2021. Everyone operating in the medical device sector will be affected one way or anoth...

UDI Helpdesk by the EU Commission!

17/5/2021

Just in time, the European Commission has launched a UDI helpdesk to support EU MDR Economic operators.

Synergies of HealthCare and Technology are leading the way!

13/5/2021

Where regulation continues to be a restraint, MedTech Companies are critical to the success factors for developing digital health care infrastructure, but these companies need to gain fast-paced momen...

Medical Devices are Trending! Here is your Trend Guide

11/5/2021

By 2021, technological advances are accelerating the revolution in the medical device industry while giving rise to new opportunities and new challenges.

A dip in Asian Healthcare Funding – Opportunity for the EU

6/5/2021

Q1 funding in the Healthcare sector has brought various changes and speculation. The European Union and the EU Market have strong growth potential.

New MDR and IVDR leave Manufacturers in Doubt as guidelines issued for Northern Ireland

4/5/2021

New guidance from the United Kingdom’s government keeps Northern Ireland in a farce. The UK issues separate guidelines for Great Britain and NI

#ScalingOurLegacy - GTC Celebrates 25 + years of Service

29/4/2021

Med-Di-Dia Congratulates Galway Technology Centre on #ScalingOurLegacy celebrating 25+ years of Service. Highlights from the virtual event!

MDCG Recent Guidance on MDR, IVDR

28/4/2021

The European Commission’s Medical Device Coordinating Group (MDCG) recently issued new guidance which explains the role of safety and performance standards under current and incoming Medical Dev...

What are the responsibilities of the EU Authorised Representative?

11/9/2020

What are the responsibilities of the EU Authorised Representative?

Can I appoint my distributor as my EU Authorised Representative?

10/9/2020

Can I appoint my distributor as my EU Authorised Representative? With the rush to ensure that UK based companies can continue to place their product on the market following Brexit, some companies...

Brexit – Time to have an EU Authorised Representative (EC Rep) in place

10/9/2020

Brexit – Time to have an EU Authorised Representative (EC Rep) in place

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