Welcome to our latest news section!
Here, we share the latest news and insights on medical device consulting, regulatory affairs, and more.
Stay informed about important topics like FDA approval, ISO 13485 compliance, and medical device registration procedures.
Learn about device validation, MDSAP, and how regulatory consultants can help your business navigate complex regulations. Whether you’re a newcomer or an expert in the field, our blog offers easy-to-understand updates to keep you informed and prepared.
Find our posts to stay ahead of regulatory changes and make sure your devices meet the highest standards.
Medical device regulation is of utmost importance in ensuring patient safety by establishing standards for the design, manufacturing, and performance of devices. These regulations mitigate risks, enforce quality management, and
The European Union’s Medical Device Regulation (MDR) stands as a comprehensive framework ensuring the safety and efficacy of medical devices within its jurisdiction. At the heart of MDR compliance lies
In 2020, India outlined plans to revamp the regulatory framework for medical devices adopting a phased approach. While manufacturers of low and low-moderate risk devices were required to comply with
In the dynamic and highly regulated medical device industry, digital transformation is not just a buzzword but a fundamental shift in operational and strategic approaches. This transformation is revolutionising the
In November 2023 Australia’s regulatory board, Therapeutic Goods Administration (TGA) released a revision of the Clinical Evidence Guideline Version 3.2. This revision sets out new guidelines on the clinical evidence
The Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled its regulatory roadmap for the development of new and robust regulations for medical devices in the UK. The new regulations
The FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation. This rule amends 21 CFR 820 by incorporating by
The European Commission’s proposal for new common specifications for certain high-risk in vitro diagnostic devices (IVDs) reflects an ongoing effort to standardize and ensure the safety and effectiveness of these
In a significant move towards modernization, the U.S. Food and Drug Administration (FDA) has issued new guidance allowing medical device manufacturers to provide user manuals in either electronic or paper
News: As of September 1, 2024, China’s National Medical Products Administration (NMPA) will enforce new classification rules for medical devices. This update marks a significant change in the regulatory landscape,
The European Union’s AI Act, set for full implementation by 2024, introduces a groundbreaking regulatory framework that will significantly impact the healthcare and medical device sectors. Together with the UK’s
