mdr guidelines
Thu
Apr, 23 2026
Founder’s Guide to First-Time ISO Certification
The pillars of any successful business are excellence, protection, and durability. ISO certification ties them...
Sat
Apr, 18 2026
ISO 14155:2026 – What the New Edition Means for Medical Device Clinical Investigations
Staying up to date in the medical device industry can be challenging, with regulatory expectations...
Wed
Apr, 15 2026
Incident Reporting Essentials for Medical Device Manufacturers
Running a medical device company involves responsibilities that extend far beyond product development and manufacturing....
Mon
Nov, 03 2025
Navigating the Complexity of Oligonucleotide Impurities
Oligonucleotide therapeutics (ONTs) represent a rapidly expanding class of biopharmaceuticals with remarkable potential for treating...
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...
Thu
Oct, 02 2025
Navigating Regulatory Complexity in Biocompatibility, Hemo-compatibility & Toxicology
As regulations continue to change, our knowledge of compliance and biological evaluation in the MedTech...
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,...
Tue
Jan, 21 2025
Writing a Declaration of Conformity (DoC)
Writing a Declaration of Conformity (DoC) is one of the most important requirement for medical device...
Fri
Dec, 27 2024
Root Cause Analysis in Medical Device Supply Chain – An Essential Guide
Root cause analysis (RCA) is a very common term used across various industries. As its...
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...
