mdr
Tue
Feb, 10 2026
The Future of MedTech Compliance: Revolutionizing Regulatory Processes with Real-Time Data
As the MedTech industry evolves rapidly, so too must the processes that ensure compliance. With...
Wed
Oct, 08 2025
Transferability of Clinical Data across the EU Population
In today’s globalized medical technology landscape, clinical research is often conducted in regions outside the...
Tue
Aug, 19 2025
Clinical Evaluation Challenges for Annex XVI Devices: – Navigating GSPRs without Clinical Benefit Claims
As Europe’s Medical Device Regulation (EU) 2017/745 (MDR) continues to shape the compliance landscape, manufacturers...
Tue
May, 13 2025
Intended Use & Indication of Use – Implications for Drafting a Technical File
The medical device regulatory sector incorporates a multitude of terms which may sound confusing. However,...
Wed
Nov, 27 2024
Approaching Supplier Corrective Action Requests
The importance of suppliers in the medical device manufacturing business cannot be denied. Without them,...
Fri
May, 24 2024
Accelerating Innovation in Medical Devices
TS Quality & Engineering (TSQ&E) is a leading international consultancy firm dedicated to supporting the...
Wed
Aug, 30 2023
Unveiling the MDR Transitional Period: Part 2 – Conditions, Evidence, Surveillance, ‘Sell-Off’ Date
Introductory Remarks Continuing our examination of the MDR/IVDR transition period, we delve into the transition period’s...
Tue
Aug, 27 2019
MDR vs MDD QUICK COMPARISON
New MDR includes the following products as devices for the first time: Rules 1 –...
Tue
Aug, 20 2019
MDR
The Regulation (EU) 2017/745 relating to medical devices, which amends Directive 2001/83 / EC (Community code relating...
Thu
Aug, 08 2019
What is UDI (Unique Device Identification)?
UDI is one small part of a complete revamp of European Medical Device (MDR) and...
Wed
Jul, 24 2019
MEDDEV 2.7.1 Rev 4 – Demystifying the new requirements
MEDDEV 2.7.1 Rev 4 – Demystifying the new requirements MEDDEV 2.7/1 is a guiding document...
