February-25 Insights: Navigating MedTech Compliance

TS Quality & Engineering Shines at Arab Health 2025

Dubai, UAE – TS Quality & Engineering recently made a remarkable impact at Arab Health 2025, one of the most prominent global healthcare exhibitions. Over four days of dynamic discussions, cutting-edge innovations, and extensive networking, the company engaged with industry leaders to explore the future of MedTech. The event heald at Dubai World Trade Center on 27th - 30th Jan 2025.

The event, held in Dubai, provided an exceptional platform for TS Quality & Engineering to showcase its expertise and connect with key stakeholders in the medical technology sector. Paolo Guerra, Global MedTech Lead, shared his enthusiasm about the event’s success, stating:

“What an incredible experience at Arab Health 2025! The energy was electric, and the passion for advancing healthcare was truly contagious. We had the opportunity to engage in inspiring conversations, discuss groundbreaking innovations, and forge valuable connections that will shape the future of healthcare.”

TS Quality & Engineering expressed gratitude to all attendees, partners, and collaborators who contributed to the engaging discussions and knowledge-sharing. The team is eager to build on the momentum gained at the event and transform these connections into meaningful partnerships.

TS Quality & Engineering Publishes New Blog on Clinical Data Management Systems

TS Quality & Engineering has released a new blog post titled “Fundamentals of Clinical Data Management System (CDMS)”, providing an insightful overview of CDMS and its critical role in ensuring data integrity and regulatory compliance in clinical research.

The blog explores key aspects of CDMS, including data collection, validation, security, and regulatory considerations, particularly in the context of EU IVDR and MDR requirements. It serves as a valuable resource for MedTech companies navigating complex clinical data requirements.

Read the full article here: Fundamentals of Clinical Data Management System (CDMS).

MHRA Issues New Guidance on Registration of Certain Medical Devices

The Medicines & Healthcare products Regulatory Agency (MHRA) has published new guidance on the registration of certain medical devices, including reusable Class I devices, unclassified Class I devices, and those reliant on expired/expiring CE certificates.

The guidance, released on 17 February 2025, provides crucial information for manufacturers navigating regulatory compliance in the UK. It addresses key registration requirements and transitional provisions, helping businesses ensure their devices remain legally marketable.

Read the full guidance document here: MHRA Guidance on Medical Device Registration.

TS Quality & Engineering Publishes Guide on Writing a Declaration of Conformity

TS Quality & Engineering has published a new blog post titled “Writing a Declaration of Conformity (DoC)”, offering essential guidance for medical device manufacturers on drafting a compliant DoC.

The article outlines the critical components of a DoC, its importance in regulatory approval, and best practices to ensure alignment with EU MDR and IVDR standards. This blog serves as a practical reference for manufacturers aiming for seamless market entry.

Read the full article here: Writing a Declaration of Conformity (DoC).

FDA Releases Draft Guidance on Compliance with 21 CFR 211.110

The U.S. Food and Drug Administration (FDA) has issued a draft guidance document titled “Considerations for Complying With 21 CFR 211.110 – Guidance for Industry”. This document aims to help pharmaceutical manufacturers ensure compliance with current good manufacturing practices (cGMP) related to in-process controls for drug products.

The draft guidance provides recommendations on best practices for monitoring, sampling, and maintaining consistency in pharmaceutical production. It is currently open for public comment, allowing industry stakeholders to provide feedback before finalization.

Read the full draft guidance here: FDA Draft Guidance on 21 CFR 211.110.

TS Quality & Engineering Explores Elements of a Device Master Record (DMR)

A new blog post from TS Quality & Engineering, “Elements of Device Master Record (DMR)”, provides an in-depth look at the essential components of a DMR and its role in medical device lifecycle management.

The blog covers the structure of a DMR, its regulatory significance, and key documentation required to maintain compliance with global standards, including EU MDR and FDA regulations. It is a must-read for MedTech professionals managing technical documentation.

Read the full article here: Elements of Device Master Record (DMR).