EVERBIZ News Center: company news, global medical device regulatory updates, and registration and compliance insights.
BS EN ISO 10993-1:2020 Biological Evaluation of Medical Devices: Overview and Where to Obtain It
ISO 10993-1 “Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process” is the foundational standard for medical device biocompatibility evaluation. BS EN ISO 10993-1:2020 is the European adoption published by the British Standards Institution (BSI), corresponding to the international standard ISO 10993-1:2018. About the standard The standard requires…
NMPA Guideline for Registration Review of Human Factors Design of Medical Devices – Download
This resource is the guideline on review of human factors (usability) design of medical devices issued by the Center for Medical Device Evaluation of the National Medical Products Administration (NMPA). About this document Human factors design focuses on use errors that may occur when users interact with a device, and the associated risks. The guideline…
EVERBIZ Austria Receives Ministry of Health Authorisation
In May 2023, EVERBIZ Austria, based in Salzburg, received authorisation from the Austrian Ministry of Health and approval in the European medical device database EUDAMED, obtaining its own SRN (Single Registration Number).
IVDR Training for Danaher’s Cepheid Successfully Completed
On 10 February 2023, EVERBIZ was honoured to be invited by Danaher’s Cepheid to deliver EU IVDR training to its regulatory affairs department. At the training, our trainer drew on many years of IVD industry experience to introduce the background and fundamentals of the IVDR, and analysed step by step the risk classification of IVD…
EVERBIZ Partners with Israel’s NEWA on Product Efficacy Verification
EVERBIZ partnered with the Israeli brand NEWA to carry out efficacy verification of NEWA radiofrequency beauty devices, verifying the products’ cosmetic effects and effectiveness. Radiofrequency (RF) refers to high-frequency alternating electromagnetic waves. These beauty devices deliver high-frequency current into the subcutaneous tissue, where the tissue’s natural resistance generates heat, stimulating the skin to produce newcollagen…
EVERBIZ and Sinotrans Carry Out GMP Validation of a Pharmaceutical Warehouse
This month, EVERBIZ Certification Services (Shanghai) Co., Ltd. was commissioned by Sinotrans Limited to provide design validation services for a warehouse of Fresenius Medical Care, the world’s largest manufacturer of haemodialysis machines, carrying out design, installation and operational qualification of a 9,000 m² pharmaceutical and medical device warehouse. This helped Fresenius pass the GMP audit…
EU Market Surveillance Regulation (EU) 2019/1020 – Download
This resource is the official English version of the EU Regulation on market surveillance and compliance of products (Regulation (EU) 2019/1020), applicable since 16 July 2021. About this document Article 4 of the Regulation requires that products within the scope of the EU harmonisation legislation it lists (CE products such as electrical equipment, toys, machinery…
EN ISO 15223-1:2016 Medical Device Labelling Symbols: Overview and Where to Obtain It
EN ISO 15223-1:2016 is the 2016 edition of the medical device labelling symbols standard as adopted in the EU. This page explains the position of this edition, its relationship with the newer edition and where to obtain the official text. About the standard The 2016 edition was widely used during the era of the EU…
EN ISO 13485:2016+A11:2021 Medical Device Quality Management Systems: Overview and Where to Obtain It
ISO 13485:2016 “Medical devices — Quality management systems — Requirements for regulatory purposes” is the quality management system standard used across the global medical device industry. EN ISO 13485:2016+A11:2021 is the European adoption, in which A11:2021 updated the annexes (Annex Z) mapping its relationship with the EU MDR/IVDR. About the standard ISO 13485 sets out…