Explore the latest insights and updates in the dynamic world of medical device regulations and quality management on our blog.
Dive deep into topics such as Regulatory Compliance, Quality Assurance, Design Control, and Verification and Validation Support.
Stay informed about the transition to the Medical Device Regulation (MDR), CE Marking requirements, and UDI compliance. Reviled
the role of European Authorized Representatives for Medical Devices and the implications of FDA Final Rule amendments.
Learn about the structure of technical files under MDR, the benefits of ISO 13485 certification, and the intricacies of implementing the UDI system for FDA compliance.
Our comprehensive articles provide valuable guidance and expertise to navigate the evolving landscape of medical device regulations and quality standards.
In the healthcare industry, ensuring the safety and effectiveness of medical devices is paramount. When issues arise that might compromise these standards, it is crucial for manufacturers and healthcare providers
The Medical Device Regulation (MDR) introduced by the European Union (EU) marks a significant overhaul in the regulation of medical devices, ensuring higher standards of safety, performance, and transparency. One
The aim of this document is to demystify the concept and purpose of a technical file as required under the Medical Device Regulation (MDR) EU 2017/745. A technical file is
Entering the Australian market with a medical device requires a thorough understanding of the regulations set by the Therapeutic Goods Administration (TGA). The Therapeutic Goods Administration (TGA) is the regulatory
As we look into medical devices within the European Union, Medical Device Vigilance and incident reporting represent critical facets of regulatory compliance aimed at safeguarding public health. The EU’s robust
Understanding the complexities of regulatory compliance is essential for medical device manufacturers aiming to enter or maintain their presence in the European market. This is particularly challenging for manufacturers outside
On January 31, 2024, the FDA issued a significant final rule amending the Quality Management System Regulation (QMSR), which aligns closely with ISO 13485:2016. This amendment marks a pivotal step
The shift towards the Medical Device Regulation (MDR) signifies a major transformation within the medical device sector in the European Union and its global partners. This journey through MDR transition
Welcome to our guide on navigating Unique Device Identification (UDI) compliance in the medical device industry. As the healthcare sector continues to evolve, the implementation of UDI systems has become
Welcome to our latest blog post where we will be looking into Own Brand Labelling (OBL) in the medical device sector. This strategy, where companies market and sell medical products
The CE marking process is a pivotal step for manufacturers looking to distribute their: This mark signifies compliance with the essential requirements of the relevant European health, safety, and environmental
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