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Elexes Medical Consulting
Elexes Medical Consulting

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Apr 18

๐Œ๐ƒ๐‘ ๐„๐ฑ๐ญ๐ž๐ง๐ฌ๐ข๐จ๐ง: ๐๐š๐ฏ๐ข๐ ๐š๐ญ๐ข๐ง๐  ๐ญ๐ก๐ž ๐‹๐š๐ญ๐ž๐ฌ๐ญ ๐‚๐ก๐š๐ง๐ ๐ž๐ฌ ๐ข๐ง ๐„๐ฎ๐ซ๐จ๐ฉ๐ž๐š๐ง ๐Œ๐ž๐๐ข๐œ๐š๐ฅ ๐ƒ๐ž๐ฏ๐ข๐œ๐ž ๐‘๐ž๐ ๐ฎ๐ฅ๐š๐ญ๐ข๐จ๐ง๐ฌ

The MDR and IVDR aim to improve the safety and performance of medical devices & IVDs, as well as increase transparency and accountability in the industry. The European Commission proposed an extension for the MDR deadline, which was later approved by the European Parliament and the Council of the European Union. The extension was granted to give manufacturers, notified bodies, and other stakeholders more time to prepare for the changes and ensure compliance with the new regulations. Let us look at the revised timeline here.

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Apr 13

๐Œ๐š๐ฑ๐ข๐ฆ๐ข๐ณ๐ข๐ง๐  ๐“๐š๐ฅ๐ž๐ง๐ญ ๐‘๐ž๐ฌ๐จ๐ฎ๐ซ๐œ๐ž๐ฌ ๐ญ๐ก๐ซ๐จ๐ฎ๐ ๐ก ๐’๐ญ๐š๐Ÿ๐Ÿ ๐€๐ฎ๐ ๐ฆ๐ž๐ง๐ญ๐š๐ญ๐ข๐จ๐ง โ€” ๐€ ๐‚๐š๐ฌ๐ž ๐’๐ญ๐ฎ๐๐ฒ

Are you looking to set up a procedure for hiring and training for your emerging healthcare organization? Look no further, Elexes is here to help you. Our dedicated team of Quality professionals with years of experience is ready to support healthcare companies throughout the hiring and training process. If you have any questions, please email us at jennifer@elexes.com. #elexes #healthcare #regulatoryconsultant #quality #hiring #training #staffaugmentation

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Apr 12

๐Š๐ง๐จ๐ฐ ๐˜๐จ๐ฎ๐ซ ๐…๐จ๐จ๐: ๐”๐ง๐๐ž๐ซ๐ฌ๐ญ๐š๐ง๐๐ข๐ง๐  ๐ญ๐ก๐ž ๐…๐š๐œ๐ญ๐ฌ ๐€๐›๐จ๐ฎ๐ญ ๐…๐จ๐จ๐ ๐€๐๐๐ข๐ญ๐ข๐ฏ๐ž๐ฌ

While food manufacturers must add additives to food products as required, however, it is also important to know the regulations applicable to both the additives and ingredients. Did you know not all of these additives are regulated and not all of them are free from the regulations? Confused? Hereโ€™s a sneak peek. #elexes #healthcare #food #additives #ingredients #regulations #usfda #safety #labeling #compliance #packaging

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๐Š๐ง๐จ๐ฐ ๐˜๐จ๐ฎ๐ซ ๐…๐จ๐จ๐: ๐”๐ง๐๐ž๐ซ๐ฌ๐ญ๐š๐ง๐๐ข๐ง๐  ๐ญ๐ก๐ž ๐…๐š๐œ๐ญ๐ฌ ๐€๐›๐จ๐ฎ๐ญ ๐…๐จ๐จ๐โ€ฆ
๐Š๐ง๐จ๐ฐ ๐˜๐จ๐ฎ๐ซ ๐…๐จ๐จ๐: ๐”๐ง๐๐ž๐ซ๐ฌ๐ญ๐š๐ง๐๐ข๐ง๐  ๐ญ๐ก๐ž ๐…๐š๐œ๐ญ๐ฌ ๐€๐›๐จ๐ฎ๐ญ ๐…๐จ๐จ๐โ€ฆ

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Apr 11

๐’๐ญ๐ซ๐ž๐š๐ฆ๐ฅ๐ข๐ง๐ข๐ง๐  ๐’๐ฎ๐ฉ๐ฉ๐ฅ๐ฒ ๐‚๐ก๐š๐ข๐ง ๐„๐Ÿ๐Ÿ๐ข๐œ๐ข๐ž๐ง๐œ๐ฒ: ๐‹๐ž๐ฌ๐ฌ๐จ๐ง๐ฌ ๐ฅ๐ž๐š๐ซ๐ง๐ž๐ ๐Ÿ๐ซ๐จ๐ฆ ๐š ๐’๐ฎ๐ฉ๐ฉ๐ฅ๐ข๐ž๐ซ ๐€๐ฎ๐๐ข๐ญ

Are you looking to conduct a supplier audit for your organization? Look no further, Elexes is here to help you. Our dedicated team of auditors with years of experience is ready to support medical device and IVD manufacturers throughout the supplier audit process. Contact jennifer@elexes.com today! #elexes #audits #internalaudit #ivd #medicaldevices #regulatoryconsultant #supplier #iso13485 #quality #qms

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Apr 8

๐‡๐š๐ฉ๐ฉ๐ฒ ๐„๐š๐ฌ๐ญ๐ž๐ซ 2023

Elexes wishes you all a joyful Easter filled with new beginnings and renewed hope. May this special day bring you happiness and blessings that last throughout the year. Happy Easter 2023! #elexes #easter2023 #HappyEaster #EasterCelebration #joy #greetings #blessings

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๐‡๐š๐ฉ๐ฉ๐ฒ ๐„๐š๐ฌ๐ญ๐ž๐ซ 2023
๐‡๐š๐ฉ๐ฉ๐ฒ ๐„๐š๐ฌ๐ญ๐ž๐ซ 2023

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Mar 29

๐๐ฎ๐ญ๐ญ๐ข๐ง๐  ๐ฒ๐จ๐ฎ๐ซ ๐›๐ž๐ฌ๐ญ ๐‚๐จ๐ฌ๐ฆ๐ž๐ญ๐ข๐œ ๐ฅ๐š๐›๐ž๐ฅ ๐Ÿ๐จ๐ซ๐ฐ๐š๐ซ๐

Did you know that the contents of a cosmetics label are subject to regulations? There is a lot to know about what should and should not be put on the package of a skincare product. Letโ€™s take a closer look at the key elements of a cosmetic label. #elexes #healthcare #cosmetics #skincare #labeling #usfda #qualityconsultant #regulations

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๐๐ฎ๐ญ๐ญ๐ข๐ง๐  ๐ฒ๐จ๐ฎ๐ซ ๐›๐ž๐ฌ๐ญ ๐‚๐จ๐ฌ๐ฆ๐ž๐ญ๐ข๐œ ๐ฅ๐š๐›๐ž๐ฅ ๐Ÿ๐จ๐ซ๐ฐ๐š๐ซ๐
๐๐ฎ๐ญ๐ญ๐ข๐ง๐  ๐ฒ๐จ๐ฎ๐ซ ๐›๐ž๐ฌ๐ญ ๐‚๐จ๐ฌ๐ฆ๐ž๐ญ๐ข๐œ ๐ฅ๐š๐›๐ž๐ฅ ๐Ÿ๐จ๐ซ๐ฐ๐š๐ซ๐

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Mar 28

๐Ž๐ฏ๐ž๐ซ๐œ๐จ๐ฆ๐ข๐ง๐  ๐ก๐ฎ๐ซ๐๐ฅ๐ž๐ฌ ๐จ๐Ÿ ๐ฅ๐š๐ฎ๐ง๐œ๐ก๐ข๐ง๐  ๐š๐ง ๐ˆ๐•๐ƒ ๐ข๐ง ๐ญ๐ก๐ž ๐„๐ฎ๐ซ๐จ๐ฉ๐ž๐š๐ง ๐ฆ๐š๐ซ๐ค๐ž๐ญ

The accuracy and reliability of an In Vitro Diagnostic (IVD) are effectively communicated via the deviceโ€™s labeling. Correct and thorough labeling benefits physicians in making informed decisions about which tests to order and how to interpret the results. For any manufacturer, serious penalties, including fines and legal responsibilities, may occur for not adhering to IVD labeling rules. With an eye on ensuring patient safety, hereโ€™s how Elexes helped an IVD manufacturer to overcome its labeling challenges while designing or updating IVD labels.

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Mar 23

โ€œ๐Œ๐š๐ฑ๐ข๐ฆ๐ข๐ณ๐ž ๐ฒ๐จ๐ฎ๐ซ ๐‘๐ž๐ ๐ฎ๐ฅ๐š๐ญ๐จ๐ซ๐ฒ ๐‚๐จ๐ง๐ฌ๐ฎ๐ฅ๐ญ๐ข๐ง๐  ๐ฐ๐ข๐ญ๐ก ๐…๐“๐„ ๐’๐ž๐ซ๐ฏ๐ข๐œ๐ž๐ฌโ€

Discover how Full-Time equivalent services can provide you with a dedicated regulatory consultant to ensure your organization stays compliant with regulations, streamlines processes, and achieves success. Watch the video to learn more about the benefits of FTE services for your regulatory needs.โ€ Get in touch with Elexes today and explore our FTE services! #elexes #qms #healthcare #patientsafety #regulatorycompliance #regulatoryconsultant #qualityconsultant #eqms #management #fte #fulltime #equivalent

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Mar 22

๐‡๐จ๐ฐ ๐ญ๐จ ๐ ๐ž๐ญ ๐ซ๐ž๐ ๐ฎ๐ฅ๐š๐ญ๐จ๐ซ๐ฒ ๐š๐ฉ๐ฉ๐ซ๐จ๐ฏ๐š๐ฅ ๐Ÿ๐จ๐ซ ๐š ๐“๐ซ๐ข๐š๐ ๐ž ๐’๐จ๐Ÿ๐ญ๐ฐ๐š๐ซ๐ž?

Would you like to place your device in the US market? Elexes can be of assistance to you. Our hardworking team has years of experience in helping customers through this process. Please get in touch with us at jennifer@elexes.com so we can examine your equipment in accordance with FDA guidelines and walk you through the necessary steps further. #elexes #fda #regulatory #quality #triage #software #usmarkets #clinicaltrials #radiology

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Mar 21

๐„๐ฅ๐ž๐œ๐ญ๐ซ๐จ๐ง๐ข๐œ ๐๐ฎ๐š๐ฅ๐ข๐ญ๐ฒ ๐Œ๐š๐ง๐š๐ ๐ž๐ฆ๐ž๐ง๐ญ ๐’๐ฒ๐ฌ๐ญ๐ž๐ฆ (๐ž๐๐Œ๐’)

โ€œ๐”๐ง๐ฅ๐จ๐œ๐ค ๐ญ๐ก๐ž ๐ฉ๐จ๐ฐ๐ž๐ซ ๐จ๐Ÿ ๐ž๐๐Œ๐’!โ€ Discover how implementing an electronic Quality Management System can streamline processes, enhance patient safety, and ensure regulatory compliance in your healthcare organization. Watch the video to learn more. Get in touch with Elexes today and know more! #elexes #QualityManagementSystem #qms #healthcare #patientsafety #regulatorycompliance #regulatoryconsultant #qualityconsultant #eqms #management #compliance

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Elexes Medical Consulting

Elexes Medical Consulting

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