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What is UDI Unique Device Identification or UDI is a system that provides harmonized positive, globally and single identification of medical devices through usage and distribution. The system has two parts, which are UDI-PI and UDI-DI. The UDI-DI is the device identifier that has the power to identify a particular device within your portfolio, which…
ISO 14971 RISK MANAGEMENT FOR MEDICAL DEVICES Let’s review the background of ISO 14971. As a medical device manufacturer, the first thing you need to do is to make sure that your devices do what they are supposed to do. Then, you need to make sure that they meet the set regulations and standards for…
ISO 13485 certification is a requirement for medical device companies that wish to market their products in Europe and around the world. What is iso 13485 certification ? The ISO 13485 standard was published by the International Standards Organization to give medical device firms with needs for developing and maintaining quality systems. While medical device…
Consultants Hiring Problems and Solutions: we will try to address here the main issues companies may encounter during and after the hiring process of a quality and regulatory affairs consultant. Lack of experience with the device classification You wouldn’t be fit to prepare some elaborate meal if all you had done so far were pasta.…
Post market surveillance in Europe One of the changes in the new European Medical Devices Regulation (MDR 2017/745) is the strengthened post market surveillance requirements for medical device manufacturers in order to register their product in the European Union. This requires manufacturers for each medical device to plan, establish, document, implement, and maintain a post…
Innovative medical devices in Korea – forecast analysis report The Korean MFDS published a forecast analysis report for innovative medical devices in South Korea. The link to the report is here. To help the medical device companies, Korean MFDS prepared and distributed the reports on the status and prospects of innovative medical devices(medical devices manufactured with…
KGMP guideline revision The Korean GMP (KGMP) guideline has been updated earlier this year (2016) and even if it was only provided in Korean we prepared a translated version in English. More details were provided in the guideline and the case of in vitro diagnostic equipment was considered since those were reclassified as medical devices.…
China International Medicinal Equipment Fair (CMEF), founded in 1979, is held twice a year – spring and autumn. After 30 years of continuous innovation and self-improvement, CMEF has become the largest exhibition of medical equipment, related products and services in the Asia-Pacific region. The exhibition widely covers ten thousands of products such as medical imaging,…
Following our webinar series where we focus on medical devices registration in South Korea, we also made it possible to join, share and discuss topics related to Korean medical devices regulation and exports to Korean market via the hashtag #medical2korea. It can be used for the following : Tweet Chats (once a week) Ad-hoc advices…
We recently launched our webinar series where we focus on medical devices registration in South Korea. We address different topics such as : How to set up the best strategy to sell your medical device in South Korea: distributors, legal terms How to get clearance from a regulatory point of view: Korean Good Manufacturing Practice,…