What information should be included in the technical file?

Oct 31, 2019 ... The CE marking reflects the manufacturer's commitment to comply with European legislation and is mandatory for placing a product on the common ... Let us guide you through the principles of CE marking step by step. We explain many of the words used in the context of CE marking, and you can get answers to ... GUILFORD, CT – February 21, 2023 — Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that created the Swoop® system, the world's ... Jul 28, 2022 ... Which medical devices require a CE mark? All medical devices sold in the EU require a CE mark. While a CE mark is not required for items such as ... Jan 25, 2021 ... The way in which a manufacturer must CE mark its device depends on the type of device in question and the regulations (MDR or IVDR) that apply. 360 Compliance is here to offer expert guidance and support through every step of the certification process, ensuring a smooth market entry. 10 steps to success: 1. Determine intended purpose 2. Determine classification 3. Determine conformity assessment routes 4. Comply with conformity requirements. 10 Steps to CE Marking. Step 1: Identify the Directive/s that is/are applicable to your product. You can download these directives free of charge from the EU ... Products with the CE mark (“Communité Européenne”) show compliance with the harmonized European Norm (hEN) standards. CE marked products can be used throughout ... The CE mark found on many electrical products is a European Economic Area mandatory conformity mark. It is a mark to identify products that are being sold ...