EUMDR Transitional Provisions – Deep Dive
Best Medical Regulatory & Quality Compliance Consultancy
MedTech Regulatory Updates in EU
Common Specifications for Borderline Medical Devices in EU
List of Common Specifications under Annex XVI – EU MDR
Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
Notified bodies survey on certifications and applications
SEHTA 2022 International MedTech Expo & Conference
IVDR Update related to EUDAMED
Funding competition Fast Start Innovation
laying down common specifications for certain class D in vitro diagnostic medical devices
Government Publishes Consultation Response on the Future Regulation of Medical Devices in the UK
Quality Management Workshop Codex4SMES
Economic Operators Workshop Codex4SMES
Summary of safety and performance Template – MDCG 2022-9
Questions and Answers on the Unique Device Identification system
MDCG Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR.
Seeking Regulatory Affairs Consultants
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL
MDCG published A Summary of safety and clinical performance
Regulatory Funding Opportunity for Health Tech SMEs
Joint implementation and preparedness plan for IVD Regulation. MDCG releases updated implementation plan for In-Vitro Diagnostic Regulations
Updates for SaMD using Blockchain
Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)
IVDR Regulation Amendment Update
MDCG advice for non EU/EEA SARS-CoV-2 infection IVD Manufacturers.
Harmonised standards updated for MDR IVDR
Medical Technologies and Advancements
Pandemics - Future and Present
Classification of Medical Devices.
Future of Medical Device Regulations
Friday Weekly Run Through 01 October
75% IVDs may Lack IVDR Certification!
Global Collaboration - Ireland and India
8 Challenges Affecting Medical Devices
Clinical Trials Information System (CTIS)
Tech Supporting Medical Services!
Med-Di-Dia's Presentation On Helix!
Latest Guidance on UDI by USFDA
Med-Di-Dia Takes Part in Innovation Workshop with ON Helix
EU MDR and the United Kingdom.
COVID-19 Survey by the EU Commission.
Med-Di-Dia and Thomas Regulatory Resolutions are using the social media platform to spread awareness about medical device regulatory affairs.
The future of Wearable Devices.
Cambridge Academy of Therapeutic Sciences announces seminar with Med-Di-Dia.
EU MDR - what’s happening with Switzerland?
MedTech Europe warns of ongoing regulatory issues
The US FDA releases draft guidelines for Medical Devices
EU plans to enforce additional regulations on MedTech AI products, other 'high-risk' systems.
Report from Deloitte Spotlights the Trend for Virtual Care
Main changes introduced by the MDR for Class I Device Manufacturers
UDI Helpdesk by the EU Commission!
Synergies of HealthCare and Technology are leading the way!
Medical Devices are Trending! Here is your Trend Guide
A dip in Asian Healthcare Funding – Opportunity for the EU
New MDR and IVDR leave Manufacturers in Doubt as guidelines issued for Northern Ireland
#ScalingOurLegacy - GTC Celebrates 25 + years of Service
MDCG Recent Guidance on MDR, IVDR
What are the responsibilities of the EU Authorised Representative?
Can I appoint my distributor as my EU Authorised Representative?
Brexit – Time to have an EU Authorised Representative (EC Rep) in place
Brexit making headlines again - What is the impact for Medtech companies market access to the EU?
Free Workshop in Galway: EU Medical Device Regulation – will your company be compliant in 8 months?
Impact of Brexit on UK and EU based Medical Device Manufacturers
Brexit seems to be getting closer to being a reality?
EU Commission needs your feedback - single-use medical devices
Another EU Notified Body leaves the ‘pond’
Europe vs. US - is the tide turning??
Second Notified Body is designated and notified under the new EU Medical Device Regulation