의료기기 이야기

[Emergo, UL] QMS Developments in South Africa: SAHPRA joins MDSAP and starts to require ISO 13485

The medical device regulator in South Africa, the South African Health Products Regulatory Authority (SAHPRA), announced two important Quality Management System (QMS) developments.SAHPRA joins MDSAPSAHPRA announced (April 4, 2025) affiliate member status has been bestowed upon the Medical Device Single Audit Program (MDSAP). SAHPRA Chief Executive Officer Dr. Boitumelo Semete-Makokotlela hailed ..

As Notified Bodies (NBs) in the European Union (EU) begin to roll out Article 16(4)  of the European Medical Devices Regulation 2017/745 (MDR) and the European In-vitro Diagnostic Medical Device Regulation 2017/746 (IVDR)  certification schemes, we at Emergo by UL share our insights on the requirements set out in Article 16 and their applicability to importers, distributors and other natural or ..

Importance of reviewing warning lettersBy reviewing relevant U.S. Food and Drug Administration (FDA) warning letters, manufacturers can better understand areas of frequent concern related to quality management systems (QMS) and regulatory affairs. This can allow companies to focus on areas of highest risk as they continually assess and improve their internal procedures and processes. It also hel..

Emergo by UL presented some of the elements to consider as part of the regulatory strategy: market and sales potential, reimbursement possibilities, academic and physician interest, and the regulatory system, including global harmonization or reliance. We use the example of South Korea where because of the public healthcare system (95% universal public healthcare system, 1989 National Health Ins..

Our second post on the new draft of the NOM for Medical Device Good Manufacturing Practices (GMP), PROY-NOM-241-SSA1-2024, discusses relevant updates concerning the restructure of content and key changes over the requirements for manufacturers, conditioners, and distributors of medical devices in Mexico. Reorganization of PROY-NOM-241-SSA1-2024This new draft contains several structural changes t..

Emergo by UL has been reporting on the landmark legislation that is the Artificial Intelligence Act (AIA). As the AIA was given the green light by EU institutions and the finish line is in sight, it seems fitting to conclude our regulatory series with a brief recap, as well as a focus on the high-risk AI systems on which the regulation is mainly concerned.RecapThe EU AIA  introduces a risk-based..

Emergo에서 아래와 같이 웨비나를 개최한다. ​ ▶ 주제: In-house tests under EU IVDR - How to best meet your IVDR deadlines ▶ 일시: 2024년 02월 28일 CST 9시 (한국시간: 03월 13일 23시) The presenter will provide more details on how to be best prepared for an external audit (FDA, MDSAP, ISO, etc.), as well as a practical approach to what to do before the audit and common pitfalls based on industry experience. We will also highligh..