MAE Group LLC

🚨 𝗢𝗻𝗹𝘆 𝟮 𝗗𝗮𝘆𝘀 𝗟𝗲𝗳𝘁! 𝗗𝗼𝗻'𝘁 𝗠𝗶𝘀𝘀 𝘁𝗵𝗲 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗦𝘁𝗮𝗿𝘁𝘂𝗽 𝗘𝘃𝗲𝗻𝘁! 🚨 The countdown is on! Only 𝟮 𝗱𝗮𝘆𝘀 until our 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗦𝘁𝗮𝗿𝘁𝘂𝗽 𝘁𝗼 𝗠𝗮𝗿𝗸𝗲𝘁 – 𝗛𝗼𝘄 𝘁𝗼 𝗕𝗲𝗮𝘁 𝘁𝗵𝗲 𝗢𝗱𝗱𝘀 seminar! If you're a MedTech innovator or entrepreneur looking to navigate the tough commercialization landscape, this is an opportunity you cannot afford to miss! 📅 𝗪𝗵𝗲𝗻: Wednesday, December 4, 2024 | 8:00 AM – 12:00 PM 📍 𝗪𝗵𝗲𝗿𝗲: Manchester Community College, Advanced Technologies Building (Room 222) 1066 Front Street, Manchester, NH 03102 🚗 𝗙𝗿𝗲𝗲 𝗣𝗮𝗿𝗸𝗶𝗻𝗴 right in front of the building! 𝗪𝗵𝘆 𝗮𝘁𝘁𝗲𝗻𝗱? ✔️ Gain expert insights on regulatory pathways, competitor analysis, and technology viability ✔️ Learn how to align your team and investors for success ✔️ Discover strategies for overcoming financial and operational hurdles ✔️ Network with top-tier industry leaders and entrepreneurs shaping the future of MedTech 𝗙𝗲𝗮𝘁𝘂𝗿𝗲𝗱 𝗦𝗽𝗲𝗮𝗸𝗲𝗿𝘀: Janet Kwiatkowski, President & CEO, MAE Group LLC Marilyn Landis, President & CEO, Basic Business Concepts Inc David Potter, Investment Funding Corporate & Startup Executive Development, Dark Horse Works 🚀 𝗥𝗘𝗚𝗜𝗦𝗧𝗘𝗥 𝗡𝗢𝗪 𝗳𝗼𝗿 𝗙𝗥𝗘𝗘! Secure your spot today: https://lnkd.in/egm7Y772 This is your last chance to register—don't wait! Share with colleagues and fellow innovators, and let's make this event one to remember. #MedTech #Startup #Innovation #Commercialization #Regulatory #Networking #Investor #MedicalDevice #Entrepreneurs #Healthcare

🚀 Don’t Miss Out on the MedTech Startup Event! 🚀 We’re just around the corner from our exciting 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗦𝘁𝗮𝗿𝘁-𝘂𝗽 𝘁𝗼 𝗠𝗮𝗿𝗸𝗲𝘁 – 𝗛𝗼𝘄 𝘁𝗼 𝗕𝗲𝗮𝘁 𝘁𝗵𝗲 𝗢𝗱𝗱𝘀 event on December 4, 2024 at Manchester Community College in Manchester, NH. This is your chance to learn from industry experts and network with fellow innovators who are shaping the future of MedTech. 𝗪𝗵𝗮𝘁’𝘀 𝗶𝗻 𝘀𝘁𝗼𝗿𝗲:  🔍 Insights into technology viability and competitor analysis 📈 Understanding regulatory pathways and investment strategies 💡 Financial management tips from experienced professionals 🤝 Networking with senior executives, entrepreneurs, and decision-makers 𝗢𝘂𝗿 𝗲𝘀𝘁𝗲𝗲𝗺𝗲𝗱 𝘀𝗽𝗲𝗮𝗸𝗲𝗿𝘀 𝗮𝗿𝗲: Janet Kwiatkowski, President & CEO, MAE Group LLC Marilyn Landis, President & CEO, Basic Business Concepts Inc David Potter, Investment Funding Corporate & Startup Executive Development, Dark Horse Works 🗓 𝗪𝗵𝗲𝗻: Wednesday, December 4, 2024 | 8:00 AM – 12:00 PM 📍 𝗪𝗵𝗲𝗿𝗲: Manchester Community College (Advanced Technologies Building – Room 222), 1066 Front Street, Manchester, NH 03102 🚗 𝗙𝗿𝗲𝗲 𝗣𝗮𝗿𝗸𝗶𝗻𝗴 available right in front of the building! 🔗 𝗥𝗘𝗚𝗜𝗦𝗧𝗘𝗥 𝗡𝗢𝗪 𝗳𝗼𝗿 𝗙𝗥𝗘𝗘: https://lnkd.in/egm7Y772 📸 Check out these images to help you easily find the venue: • 𝗣𝗮𝗿𝗸𝗶𝗻𝗴 𝗹𝗼𝘁 𝗮𝗻𝗱 𝗲𝘃𝗲𝗻𝘁 𝗯𝘂𝗶𝗹𝗱𝗶𝗻𝗴 – You can park right in front of the building for convenience! • 𝗖𝗹𝗮𝘀𝘀𝗿𝗼𝗼𝗺 𝗲𝗻𝘁𝗿𝗮𝗻𝗰𝗲 – The event will take place in Room 222, set up for an engaging and interactive experience. Don't forget to share with colleagues and fellow innovators who could benefit from this valuable opportunity. We look forward to seeing you there! #medtech #medicaldevice #commercialization #investor #finance #regulatory #design #development #reimbursement

𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗦𝘁𝗮𝗿𝘁-𝘂𝗽 𝘁𝗼 𝗠𝗮𝗿𝗸𝗲𝘁 – 𝗛𝗼𝘄 𝘁𝗼 𝗕𝗲𝗮𝘁 𝘁𝗵𝗲 𝗢𝗱𝗱𝘀 Join us at an upcoming event for MedTech startups on 𝗗𝗲𝗰𝗲𝗺𝗯𝗲𝗿 𝟰, 𝟮𝟬𝟮𝟰, at 𝗠𝗮𝗻𝗰𝗵𝗲𝘀𝘁𝗲𝗿 𝗖𝗼𝗺𝗺𝘂𝗻𝗶𝘁𝘆 𝗖𝗼𝗹𝗹𝗲𝗴𝗲 in Manchester, NH. The event is designed to assist MedTech startups in navigating the commercialization process, with a focus on the integration of technology viability and competitors, regulatory pathway to market, investors perspective and financial management.  The event is geared towards senior operational executives, entrepreneurs, medtech decision makers, and innovators considering launching new venture. Participants get access to experienced professionals who have pulled together talented teams that have integrated multi-functional areas Our esteemed speakers are: Janet Kwiatkowski, President & CEO, MAE Group LLC Marilyn Landis, President & CEO, Basic Business Concepts Inc David Potter, Investment Funding Corporate & Startup Executive Development, Dark Horse Works 💵𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗻𝗼𝘄 𝗳𝗼𝗿 𝗙𝗿𝗲𝗲! 🕗𝗪𝗵𝗲𝗻: 𝗪𝗲𝗱𝗻𝗲𝘀𝗱𝗮𝘆 𝗗𝗲𝗰𝗲𝗺𝗯𝗲𝗿 𝟰, 𝟮𝟬𝟮𝟰 𝟴:𝟬𝟬 𝗮𝗺 - 𝟭𝟮:𝟬𝟬 𝗽𝗺  📍𝗪𝗵𝗲𝗿𝗲: 𝗠𝗮𝗻𝗰𝗵𝗲𝘀𝘁𝗲𝗿 𝗖𝗼𝗺𝗺𝘂𝗻𝗶𝘁𝘆 𝗖𝗼𝗹𝗹𝗲𝗴𝗲 (𝗔𝗱𝘃𝗮𝗻𝗰𝗲𝗱 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆           𝗕𝘂𝗶𝗹𝗱𝗶𝗻𝗴 – 𝗥𝗼𝗼𝗺 𝟮𝟮𝟮)          𝟭𝟬𝟲𝟲 𝗙𝗿𝗼𝗻𝘁 𝗦𝘁𝗿𝗲𝗲𝘁           𝗠𝗮𝗻𝗰𝗵𝗲𝘀𝘁𝗲𝗿, 𝗡𝗛 𝟬𝟯𝟭𝟬𝟮  🚗𝗙𝗿𝗲𝗲 𝗽𝗮𝗿𝗸𝗶𝗻𝗴 𝗶𝗻 𝗳𝗿𝗼𝗻𝘁 𝗼𝗳 𝗯𝘂𝗶𝗹𝗱𝗶𝗻𝗴 Registration is open: https://lnkd.in/egm7Y772 Attendees are encouraged to share this opportunity with colleagues. #medtech #medicaldevice #commercialization #investor #finance #regulatory #design #development #reimbursement

𝗠𝗔𝗘 𝗚𝗥𝗢𝗨𝗣 𝗜𝗦 𝗘𝗫𝗖𝗜𝗧𝗘𝗗 𝗧𝗢 𝗢𝗥𝗚𝗔𝗡𝗜𝗭𝗘 𝗜𝗧'𝗦 𝗙𝗜𝗥𝗦𝗧 𝙈𝙀𝘿𝙏𝙀𝘾𝙃 𝙎𝙏𝘼𝙍𝙏𝙐𝙋 𝙏𝙊 𝙈𝘼𝙍𝙆𝙀𝙏 𝗪𝗢𝗥𝗞𝗦𝗛𝗢𝗣! 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗦𝘁𝗮𝗿𝘁𝘂𝗽 𝘁𝗼 𝗠𝗮𝗿𝗸𝗲𝘁: 𝗛𝗼𝘄 𝘁𝗼 𝗕𝗲𝗮𝘁 𝘁𝗵𝗲 𝗢𝗱𝗱𝘀 The MedTech startup world is tough, with failure rates as high as 98%. Why? A critical gap in commercialization expertise. Building a successful medtech venture requires a deep understanding of product design, regulatory compliance, market needs, financial strategy, reimbursement models, and much more. 𝗝𝗼𝗶𝗻 𝘂𝘀 𝗳𝗼𝗿 𝗮 𝗙𝗥𝗘𝗘 𝗲𝘃𝗲𝗻𝘁 to learn from seasoned professionals who’ve navigated these challenges and turned their ventures into success stories. 𝗘𝘃𝗲𝗻𝘁 𝗗𝗲𝘁𝗮𝗶𝗹𝘀: 𝗗𝗮𝘁𝗲: Wednesday, December 4, 2024 𝗧𝗶𝗺𝗲: 8:00 AM - 12:00 PM 𝗟𝗼𝗰𝗮𝘁𝗶𝗼𝗻: Manchester Community College, 1066 Front Street, Manchester, NH 03102 𝗖𝗼𝘀𝘁: FREE! 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿: https://lnkd.in/egm7Y772? 𝗪𝗵𝗼 𝘀𝗵𝗼𝘂𝗹𝗱 𝗮𝘁𝘁𝗲𝗻𝗱? • Senior executives in operations and strategy • Entrepreneurs and innovators looking to launch medtech ventures • Medtech decision-makers and investors • Anyone passionate about overcoming the challenges of commercialization 𝗪𝗵𝗮𝘁 𝘄𝗶𝗹𝗹 𝘆𝗼𝘂 𝗹𝗲𝗮𝗿𝗻? • Navigating regulatory, financial, and operational hurdles • Gaining insights on market adoption and reimbursement strategies • How to align your team and investors for long-term success • How to navigate the commercialization pathway This event is a unique opportunity to 𝗰𝗼𝗻𝗻𝗲𝗰𝘁, 𝗹𝗲𝗮𝗿𝗻, 𝗮𝗻𝗱 𝗴𝗿𝗼𝘄. Don’t miss out on key networking opportunities and expert advice that can help you accelerate your startup’s path to success. Read the flyer for more details. 𝗥𝗦𝗩𝗣 𝗻𝗼𝘄 and share with colleagues who would benefit from this invaluable opportunity! #medtech #medicaldevice #commercialization #investor #finance #regulatory #design #development #reimbursement

MAE Group, a leading MedTech business service provider, specializes in design, development, AI, biomedical engineering, regulatory, quality systems, and project management. We collaborate with global MedTech companies to introduce life-enhancing and life-saving medical devices to international markets. Connect with us to streamline and cost-effectively launch your product into the market. #MedTech #MedicalDevices #Innovation #Cybersecurity #Design #Prototype #Engineering #Regulatory #Commercialization

𝐔𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝𝐢𝐧𝐠 𝐅𝐃𝐀'𝐬 𝟓𝟏𝟑(𝐠) 𝐑𝐞𝐪𝐮𝐞𝐬𝐭 Section 513(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) offers a pathway for manufacturers to seek the FDA's guidance on the classification and regulatory requirements of medical devices. Here’s an essential breakdown for industry professionals: 𝐖𝐡𝐚𝐭 𝐢𝐬 𝐚 𝟓𝟏𝟑(𝐠) 𝐑𝐞𝐪𝐮𝐞𝐬𝐭? A 513(g) Request allows manufacturers to obtain the FDA's views on:  1. The classification of a device. 2. The regulatory requirements applicable to the device. 𝐊𝐞𝐲 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐬 𝐨𝐟 𝐚 𝟓𝟏𝟑(𝐠) 𝐑𝐞𝐪𝐮𝐞𝐬𝐭: Response Time: The FDA will provide a written statement within 60 days from the receipt of the request. Scope: Only information on classification and regulatory requirements is provided. No reviews on substantial equivalence or safety and effectiveness are conducted. 𝐂𝐨𝐧𝐭𝐞𝐧𝐭𝐬 𝐨𝐟 𝐚 𝟓𝟏𝟑(𝐠) 𝐑𝐞𝐪𝐮𝐞𝐬𝐭: To submit a comprehensive 513(g) Request, include the following: 1. Cover Letter: • Date of the request. • Name of the device. • Specific questions regarding classification and regulatory requirements. • Contact information (name, address, telephone number, email). • Requestor’s signature. 2. Device Description: • List of materials and components. • Photographs, engineering drawings, and/or samples. • Operational principles. • Type and amount of energy used or delivered. • Description of similar devices in the market. 3. Intended Use: • Disease or condition the device addresses. • Target patient population. 4. Labeling: • Any proposed labeling or promotional material for the device and/or promotional material of a similar, legally marketed device, if available. 𝐅𝐃𝐀’𝐬 𝐑𝐞𝐬𝐩𝐨𝐧𝐬𝐞: The FDA’s response will generally include: • Classification Assessment: Based on the provided information, the FDA will assess the generic type of the device and its class. • Regulatory Requirements: Indicate whether a PMA (Premarket Approval), 510(k) (Premarket Notification), or neither is required. • Additional Requirements: Identify if additional requirements such as those for radiation-emitting products apply. 𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐚𝐧𝐝 𝐅𝐞𝐞𝐬: Submit your 513(g) Request electronically or as a paper copy to the appropriate address found on the FDA’s website. Note that user fees apply, and the FDA will not begin the review until all fees are paid. For more detailed instructions and examples, visit the FDA's guidance document on Section 513(g) Requests: https://lnkd.in/e8FGPqzQ At MAE Group, we specialize in guiding medical device innovators through the complexities of FDA regulatory processes. Connect with Darshan Bhaiya, our Regulatory Affairs Specialist at darshanb@maegroups.com to assistance in navigating the 513(g) request. Visit our website: https://lnkd.in/dX-QT9_2

𝐔𝐧𝐥𝐨𝐜𝐤𝐢𝐧𝐠 𝐅𝐃𝐀 𝐏𝐫𝐞-𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧𝐬: 𝐘𝐨𝐮𝐫 𝐊𝐞𝐲 𝐭𝐨 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐒𝐮𝐜𝐜𝐞𝐬𝐬!   Q-Submissions provide sponsors and applicants with a strategic advantage to proactively seek FDA feedback and guidance, enhancing the path to successful submissions and gaining a competitive edge in the regulatory landscape. One of the most popular and highly utilized Q-Submission meetings with the FDA is the Pre-Submission meeting. It can be requested for an intended premarket submission (IDE, PMA, HDE, De Novo request, 510(k), CW, Dual, Accessory Classification Request, BLA, or IND).   𝐖𝐡𝐚𝐭 𝐝𝐨𝐞𝐬 𝐢𝐭 𝐢𝐧𝐜𝐥𝐮𝐝𝐞?   The process of arranging a pre-submission meeting hinges on creating a meticulously assembled request package. This package typically includes the preferred method of feedback, a draft agenda with estimated time allocations for each topic, a detailed device description, proposed indications for use, regulatory history, specific questions for feedback, and other pertinent details. Such careful preparation ensures that the meeting with the FDA is focused, productive, and aligned with achieving regulatory goals effectively.   𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐌𝐞𝐭𝐡𝐨𝐝𝐬 𝐚𝐧𝐝 𝐊𝐞𝐲 𝐓𝐢𝐦𝐞𝐥𝐢𝐧𝐞𝐬:   It can be submitted to FDA through eSTAR or eCopy. The FDA sends notification within 15 days notifying submitter of acceptance or technical screening outcome, including lead reviewer contact. If no meeting is requested, written feedback is provided within 70 days. If a meeting is requested, written feedback is provided within 70 days or 5 days prior to scheduled meeting whichever is sooner. If all the submitter’s questions are addressed to the submitter’s satisfaction through the written feedback, the submitter may cancel the meeting and the written response will serve as the official record of the FDA. The meeting minutes need to be submitted to FDA by the submitter within 15 days of the meeting. Currently most pre-subs are held virtually but FDA is amenable for in-person sessions.   At MAE Group, we specialize in guiding medical device innovators through the complexities of FDA regulatory processes. Our team of experts can assist you in navigating the Q-Submission process, ensuring your submission is well-prepared and aligned with FDA expectations. Ready to streamline your FDA journey? Connect with Darshan Bhaiya, our Regulatory Affairs Specialist at darshanb@maegroups.com to learn how MAE Group can support your regulatory needs. Visit our website: https://lnkd.in/dX-QT9_2 Read the Q-Submission Guidance here: https://lnkd.in/gJEa6RTp

𝐆𝐥𝐢𝐨𝐛𝐥𝐚𝐬𝐭𝐨𝐦𝐚 𝐀𝐰𝐚𝐫𝐞𝐧𝐞𝐬𝐬 𝐃𝐚𝐲! More than 14,000 Americans will receive a Glioblastoma (GBM) diagnosis this year. The average life expectancy when someone is diagnosed with GBM is 12-18 months. These patients, and patients of other aggressive cancers, do not have the time it traditionally takes to advance new treatment options through clinical trials to FDA approval. In an effort to help save more patient lives from this devastating diagnosis, National Foundation for Cancer Research (NFCR) President & CEO Dr. Sujuan Ba fought relentlessly to help create the revolutionary clinical trial platform, GBM AGILE (Glioblastoma Adaptive Innovative Learning Environment), a paradigm-shifting clinical trial system to speed up the clinical trial process to bring new treatments and drugs to brain cancer patients. To date more than 2,400 Patients have been screened, and there are 75+ trials sites set up worldwide. Dr. Ba envisions a future where this trial system is applied to other deadly cancers that present poor prognoses for patients, such as ovarian and pancreatic cancers. Cancer patients deserve more time. More research and more breakthrough discoveries can help make this possible. Show your support here: https://lnkd.in/eAZMhuG7

𝗨𝗻𝗱𝗲𝗿𝘀𝘁𝗮𝗻𝗱𝗶𝗻𝗴 𝘁𝗵𝗲 𝗙𝗗𝗔 𝗤-𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗣𝗿𝗼𝗴𝗿𝗮𝗺 Q-Submission Program is a mechanism available to submitters through which they can request interactions with the FDA related to medical device submissions. These interactions can include written feedback and/or a meeting related to potential or submitted medical device.  𝐁𝐞𝐧𝐞𝐟𝐢𝐭𝐬 𝐨𝐟 𝐭𝐡𝐞 𝐐-𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐏𝐫𝐨𝐠𝐫𝐚𝐦: • Understand the FDA's perspective on your device's development and regulatory strategy. • Resolve questions about data requirements, clinical studies, and more before committing resources.  • Increase efficiency by addressing FDA concerns upfront, potentially shortening review times 𝐓𝐲𝐩𝐞𝐬 𝐨𝐟 𝐐-𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧𝐬: • Pre-Submissions: It is a request for FDA feedback prior to an intended premarket submission (IDE, PMA, HDE, De Novo request, 510(k), CW, Dual, Accessory Classification Request, BLA, or IND). • Submission Issue Requests (SIRs): It is a request for FDA feedback via written feedback or a meeting on a proposed approach to address issues conveyed in a marketing submission hold letter, a CW hold letter, an IDE Letter, or an IND Clinical Hold letter. • Study Risk Determinations: It is a request for FDA determination for whether a planned medical device clinical investigation is significant risk (SR), nonsignificant risk (NSR), or exempt from most requirements under the IDE regulations. • PMA Day 100 Meetings: It is a FDA meeting held within 100 days of receiving a PMA application, allowing discussion on its review status as requested by the applicant. • Other Q-Submission Types:    1. Agreement and Determination Meetings    2. Submissions associated with Breakthrough Devices Program   3. Submissions associated with Safer Technologies Program    4. Accessory Classification Requests • Informational Meetings: It allows for sharing information with the FDA without expecting feedback. It is used to establish interactions not covered by specific Q-Sub types. At MAE Group, we specialize in guiding medical device innovators through the complexities of FDA regulatory processes. Our team of experts can assist you in navigating the Q-Submission process, ensuring your submission is well-prepared and aligned with FDA expectations. Ready to streamline your FDA journey? Connect with Darshan Bhaiya, our Regulatory Affairs Specialist at darshanb@maegroups.com to learn how MAE Group can support your regulatory needs.  Visit our website: https://lnkd.in/dX-QT9_2 Read the Q-Submission guidance here: https://lnkd.in/gJEa6RTp Stay tuned to learn more about the intricacies, and nuances associated with a Pre-submission meeting request with the FDA in our upcoming post. #FDARegulation #MedicalDevices #FDAConsulting #RegulatoryStrategy #QSubmissionMeeting

𝐔𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝𝐢𝐧𝐠 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐑𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭𝐬: 𝐅𝐃𝐀 𝐯𝐬. 𝐈𝐒𝐎 𝐟𝐨𝐫 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐥 𝐀𝐮𝐝𝐢𝐭𝐬 Navigating the regulatory landscape for medical device quality management systems can be challenging. Two key standards that often come into play are the FDA's 21 CFR Part 820 Quality System Regulation and ISO 13485:2016 Quality Management Systems. Here's a quick comparison: 𝐅𝐃𝐀 § 𝟖𝟐𝟎.𝟐𝟐 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐀𝐮𝐝𝐢𝐭: 𝐏𝐮𝐫𝐩𝐨𝐬𝐞: Ensure compliance with established quality system requirements and assess effectiveness. 𝐈𝐧𝐝𝐞𝐩𝐞𝐧𝐝𝐞𝐧𝐜𝐞: Conducted by individuals without direct responsibility for the matters audited. 𝐀𝐜𝐭𝐢𝐨𝐧𝐬: Implement corrective actions and reaudits when necessary. 𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧: Maintain records of audit dates, results, and follow-up actions. 𝐈𝐒𝐎 𝟏𝟑𝟒𝟖𝟓:𝟐𝟎𝟏𝟔 𝟖.𝟐.𝟒 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐥 𝐀𝐮𝐝𝐢𝐭: 𝐏𝐮𝐫𝐩𝐨𝐬𝐞: Verify conformity to planned arrangements, ISO standards, and regulatory requirements. 𝐈𝐧𝐝𝐞𝐩𝐞𝐧𝐝𝐞𝐧𝐜𝐞: Auditors must be objective and impartial, not auditing their own work. 𝐏𝐥𝐚𝐧𝐧𝐢𝐧𝐠: Audit program should consider process status, importance, and past results. 𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧: Keep detailed records of audit criteria, scope, methods, results, and corrective actions. Both standards emphasize the importance of thorough, unbiased audits and detailed documentation. However, the nuances in their requirements can impact your compliance strategy. At MAE Group, we understand that each medical device company has unique needs when it comes to regulatory compliance. Our team of experienced auditors is well-versed in both FDA and ISO standards, ensuring that your internal audits not only meet but exceed regulatory expectations. We provide a comprehensive audit service that includes meticulous planning, execution, and follow-up, all designed to enhance the effectiveness of your quality management system. We work closely with your team to ensure all audit findings are documented, corrective actions are effectively implemented, and continuous improvement is achieved. By choosing us, you’re not just meeting regulatory requirements—you’re committing to the highest standards of quality and safety for your medical devices.  Learn more about our services here: https://lnkd.in/e4QasH27 Connect with Jay Bijesh Shah, our Biomedical Engineer at jays@maegroups.com to learn how MAE Group can support your medical device quality management needs! #MAEGroup #MedicalDevices #QualityManagement #FDA #ISO13485 #InternalAudit #RegulatoryCompliance #QualityAssurance