NEWS
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ISO 10993 testing standards and testing items
IS0 10993 is a series of biocompatibility evaluation standards issued by the International Organization for Standardization (IS0) to evaluate the safety of biomaterials for in vivo use. Among them, ISO 109931 is the general principle of this series of standards, which specifies the overall requiremeRead more -
Introduction to the New MDR Regulations of the EU Medical Device Directive
A website is an important part of your business's marketing and sales success, but how do you get started and structure a website strategy that aligns with your marketing and business goals?Everyone knows that websites are good for business. Think about it, when you are interested in a product oRead more -
Inventory: 2023 US FDA Medical Device Regulatory Milestones
1. Approval of the first CLIA exempted respiratory infectious disease joint testing productOn February 3, FDA approved the in vitro diagnostic product BioFire SPOTFIRE Respiratory (R) Panel, which is used to simultaneously detect and identify suspected COVID-19 infection and other respiratory viralRead more -
General requirements for clinical evaluation based on clinical data of the same type of medical device
A well-tuned marketing strategy can make your brand a success.While the principles for developing a marketing strategy remain the same, in 2022 alone we will see a significant shift towards different types of content, such as short videos. So, for example, you need to start with a customer problem,Read more -
PPE Directive (EU) 2016/425
PPE Directive (EU) 2016/4251、 Definition and Purpose of EU Directive 2016/425The EU PPE Directive EU 2016/425 applies to Personal Protective Equipment (PPE), which sets out the conditions for its placement and free movement on a single market. In addition, it includes all basic safety requirementsRead more -
The role and significance of inspection reports
What is the purpose of the inspection reportAn inspection report is a document used to record and present the inspection results of a product, material, or process. These reports are typically generated by testing laboratories, certification bodies, or quality control departments and used in variousRead more -
EU testing standards for protective gloves and inspection gloves
According to the penetration resistance test similar to EN374 Part 2, evaluate tests for non porosity and evaluate the mechanical strength of glove size and materials, including tests before and after aging.EN 455 was initially written to support the Medical Device City Directive, but due to variousRead more -
The main role of ISO9001 quality management system
The role of the ISO9001 quality management system is mainly reflected in improving product quality, protecting consumer interests, enhancing enterprise management capabilities, promoting continuous improvement, meeting customer needs, promoting international trade, reducing product costs, improvingRead more