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Explore the 5 major requirements of UDI (Unique Device Identifier) set by U.S. FDA. Right from the deciding on UDI for your label to providing identifying information to the FDA’s GUDID database for accessibility & use, you have to meet all these 5 requirements. You can get help of professionals at Elexes. #medicaldevices #medicaldevice #medicaldevicemanufacturing #medicaldeviceindustry #medicaldeviceregulation #medicaldevicedesign #medicaldeviceregulatory #medicaltechnology #medtech #medicaltech #medtechinnovation #medtechinnovator #medicine  #fda #fdaapproval

In a significant regulatory update, #Mexico’s Federal Commission for the Protection against Sanitary Risk (#COFEPRIS) has introduced new guidelines for #MedicalDevice registrations. The changes, which came into effect in August 2023, aim to streamline the review process and address the backlog of applications. New Classification Criteria The revised guideline, released in response to OFICIO-CFS-325-2023, establishes fresh criteria for the modification of sanitary registrations of medical devices. This includes a clear definition of terms such as ‘Legal Manufacturer’ and ‘Real Manufacturer,’ ensuring clarity in the application process. Electronic Submission A notable shift is the move towards electronic submission of modifications. Applicants must now submit changes electronically, albeit in person, using a marked USB flash drive. Impact on Manufacturers Manufacturers must ensure that the original registration route is maintained through subsequent modifications. The guideline emphasizes the importance of selecting the best registration route for the device throughout its lifecycle. Global Implications These updates by COFEPRIS are expected to have a positive impact on the medical device industry, both domestically and internationally, by expediting the registration process and bringing innovative medical devices to the market more swiftly. Read more details in the article here. https://lnkd.in/gwVG2_Kv

FDA an important step closer to ISO 13485:2016 ISO 13485:2016 is the well established international quality standard for manufacturers of medical devices. With the US market increasingly looking attractive for UK and EU manufacturers, the FDA has always been walking to a different step with their 21 CFR Part 820. On 31st January 2024, a key move was made by the FDA in issuing their final rule amending the 'Quality System Regulation' (QSR) to better align with ISO 13485:2016. Instead, the QMSR becomes the new name as the 'Quality Management System Regulation', so hello QMSR and farewell 'QSR'. The date to work to is 2nd February 2026 for enforcement of the QMSR. We know that 'tempus fugit' , so manufacturers need to use the 2 year period, starting from now. However, better alignment around the world should lead to simplification, lower cost for compliance, and more time efficiency for medical device manufacturers. So what is the difference? In short, this means that the new FDA QMSR converges even more with ISO 13485:2016, and will directly reference requirements from it, changing the way that 21 CFR Part 820 appears once the QMSR is brought into effect. All in all, this is good news for the medical device industry.

Are you ready to ace FDA approval?   Our article brings you one important step closer📢   "Human Factors Validation – Basics at a Glance (Part 1)" gives you access to valuable insights into conducting a successful Human Factors Validation Study, essential for FDA approval of your medical device.   Read it here: https://lnkd.in/ekQJ-XN7     What is your most valuable insight when it comes to conducting a Human Factors Validation?   #HumanFactors #MedicalDevices #FDAApproval #HealthcareSafety

Navigate the complexities of #medicaldevice classification effortlessly with our expert guide. 📚 Understand the nuances of determining your medical device class and ensure #compliance with #regulatory standards. 💡Our comprehensive insights and practical tips empower you to make informed decisions, guiding your path to successful #classification in the dynamic healthcare landscape. Stay ahead of regulatory requirements and position your medical device for success with our essential classification #guide. ⏬

Are you struggling to establish a complaint-handling process that complies with FDA regulations? We've got you covered! In partnership with Greenlight Guru, we are giving away a Complaint Template Bundle! This tool is designed specifically for medical device companies, including LDT/IVD manufacturers to meet FDA requirements. What's included: ✅ Customizable Complaint Log Template ✅ Easy-to-use Complaint Form Template This bundle is available free of charge to help you enhance patient safety and maintain FDA compliance. Don’t miss out! Download Here: https://lnkd.in/ehGs4mfE #FDA #Complaint #Compliance #Resource #LookToRook #GreenlightGuru

Are you a medical device manufacturer aiming to bring a new sterile medical device to market in the United States? 🇺🇸 Understanding the FDA's 510(k) pre-market notification process is crucial for success. Our latest blog post on 8C Healthcare dives deep into the intricate requirements for submitting a 510(k) pre-market notification for sterile medical devices to the US FDA. From documentation to testing standards, we've got you covered! Read the full article here: https://lnkd.in/e2z_cFE2 Stay ahead in the competitive healthcare landscape with 8C Healthcare's expert insights. #MedicalDeviceInnovation #USFDARegulations #medtechCompliance #MedicalDeviceDevelopment #510kSubmission #SterileDevices #USFDA #CDRH #premarketnotification #8chealthcare

Recognizing what to expect during a Medical Device FDA inspection enables a medical device manufacturer to effectively prepare. Don't risk costly setbacks during FDA inspections. Join our expert led preparedness course and arm yourself with expert insights and practical guidance to navigate inspections successfully. Register today: https://bit.ly/3LBWfhH #medicaldevices #training #FDA #nsflearn

🤗 Here are the medical device reporting (MDR) basic requirements for those who need to know! Healthcare Innovation Catalysts #HICexplains #HIC #FDA #MDR #MedicalDevices

It’s good to know the basics! Do you know the basic requirements for medical device reporting (MDR) (21 CFR Part 803)? Here is a quick run-down for manufacturers.   Basic requirements of MDR for manufacturers are: ✅ Submit reports of MDR reportable events (21 CFR 803.10(c) and 803.50) ✅ Develop maintain, and implement written procedures for the identification and evaluation of all medical device events (e.g., malfunctions, serious injuries, and deaths) to determine whether the event is an MDR reportable event (21 CFR 803.17) ✅ Establish and maintain complete files for all complaints concerning medical device events (21 CFR 803.18)   To submit an MDR reportable event, use an electronic equivalent Form 3500A approved by FDA. Information requirements are: ✅ Information that you can obtain by contacting a user facility, importer, or other initial reporter. ✅ Information in your possession. ✅ Information obtained by analysis, testing, or other evaluation of the device.   To learn more, visit https://lnkd.in/eHakrxKH If you need help navigating these regulations, we can help! Contact us at FindExperts@hicatalysts.com.   Stay tuned next week for our post on the requirements on the 3 types of MDR reports. Keep informed for compliance excellence! #LDT #MDR #FDA #Healthcare #Regulations #Manufacturers