AlvaMed, Inc.

𝗢𝘃𝗲𝗿𝗰𝗼𝗺𝗶𝗻𝗴 𝗔𝘂𝗱𝗶𝘁 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝘄𝗶𝘁𝗵 𝗔𝗹𝘃𝗮𝗠𝗲𝗱'𝘀 𝗘𝘅𝗽𝗲𝗿𝘁 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 AlvaMed recently had the opportunity to work with a small start-up to complete their internal audits so their focus could remain on product development. With limited internal resources and the need to comply with ISO 13485:2016 and 21 CFR Parts 820, 803, & 806, they turned to AlvaMed for help. Our team of experts delivered comprehensive audit support with the following approach: • 𝗖𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝘃𝗲 𝗣𝗹𝗮𝗻: We worked closely with the client to understand their unique needs and crafted a flexible schedule that aligned with their product launch priorities. • 𝗘𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝘁 𝗘𝘅𝗲𝗰𝘂𝘁𝗶𝗼𝗻: Clear communication, timely feedback, and strict adherence to project timelines ensured a smooth process and successful audit completion.  AlvaMed partnered with the client to help maintain their QMS process and assess any gaps in regulatory compliance, demonstrating the significant impact AlvaMed’s assistance has on a medical device manufacturer’s success. Read the full case study here:  https://lnkd.in/euWHt8qf #MedTech #RegulatoryCompliance #ISO13485 #MedicalDevices 

𝗡𝗲𝘄 𝗬𝗲𝗮𝗿, 𝗡𝗲𝘄 𝗚𝗼𝗮𝗹𝘀: 𝗘𝗹𝗲𝘃𝗮𝘁𝗲 𝗬𝗼𝘂𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 Is launching new products or expanding into new markets a key goal for 2025? AlvaMed's regulatory experts can help you navigate complex regulatory challenges and achieve your business objectives. We provide strategic guidance to: • 𝗠𝗶𝗻𝗶𝗺𝗶𝘇𝗲 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗿𝗶𝘀𝗸 • 𝗦𝘁𝗿𝗲𝗮𝗺𝗹𝗶𝗻𝗲 𝘆𝗼𝘂𝗿 𝗽𝗮𝘁𝗵 𝘁𝗼 𝗺𝗮𝗿𝗸𝗲𝘁 • 𝗠𝗮𝘅𝗶𝗺𝗶𝘇𝗲 𝘆𝗼𝘂𝗿 𝗰𝗵𝗮𝗻𝗰𝗲𝘀 𝗼𝗳 𝘀𝘂𝗰𝗰𝗲𝘀𝘀 Learn more about our regulatory strategy services: https://lnkd.in/eYxF_pDn #MedicalDevices #RegulatoryAffairs #FDA #EMA #RegulatoryStrategy

𝐀𝐫𝐭𝐢𝐟𝐢𝐜𝐢𝐚𝐥 𝐈𝐧𝐭𝐞𝐥𝐥𝐢𝐠𝐞𝐧𝐜𝐞-𝐄𝐧𝐚𝐛𝐥𝐞𝐝 𝐃𝐞𝐯𝐢𝐜𝐞 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐅𝐮𝐧𝐜𝐭𝐢𝐨𝐧𝐬: 𝐋𝐢𝐟𝐞𝐜𝐲𝐜𝐥𝐞 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐚𝐧𝐝 𝐌𝐚𝐫𝐤𝐞𝐭𝐢𝐧𝐠 𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐑𝐞𝐜𝐨𝐦𝐦𝐞𝐧𝐝𝐚𝐭𝐢𝐨𝐧𝐬 On January 7, 2025, the FDA issued a draft guidance document on “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations”. The draft guidance outlines recommendations for marketing submissions of devices with AI-enabled software functions, emphasizing documentation that supports FDA's evaluation of safety and effectiveness. It provides a risk-based approach throughout the device's total product life cycle (TPLC) and suggests strategies for the design, development, deployment, and maintenance of AI-enabled devices. Key recommendations include managing transparency and bias, essential considerations in AI-enabled device design to ensure safety and effectiveness. Transparency involves making critical information accessible and comprehensible, facilitating usability and informed decision-making. Addressing bias entails ensuring representativeness in data collection and evaluating device performance across diverse subgroups, mitigating the risks of systematic inaccuracies affecting specific populations. The guidance also highlights challenges such as data drift, where discrepancies between development and deployment data may impact device performance. It proposes strategies like implementing a predetermined change control plan (PCCP) to allow prospective modifications to improve device functionality without requiring repeated FDA submissions. While the recommendations broadly apply to all AI-enabled devices, particular emphasis is placed on machine learning, including deep learning and neural networks. For transparency and bias control, the guidance offers design recommendations and emphasizes performance management throughout the TPLC. Additionally, it incorporates insights from prior regulatory experiences and current research, underscoring the need for comprehensive documentation to support marketing submissions. By addressing these elements, the guidance aims to ensure the continued development and safe implementation of AI-enabled devices in diverse healthcare settings. Read the full guidance here: https://lnkd.in/e6dvKAak For more industry news and insights, visit our website: https://lnkd.in/dA4j5s-9

𝐀 𝐂𝐑𝐎 𝐂𝐚𝐬𝐞 𝐒𝐭𝐮𝐝𝐲: 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐲 & 𝐏𝐫𝐨𝐭𝐨𝐜𝐨𝐥 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭  A small medical device company developing an innovative robotic platform for precision surgery sought AlvaMed’s assistant for CRO support. 𝐓𝐡𝐞 𝐂𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞: The client needed to develop a rapid and cost-effective path to clinical trial initiation working within a tight budget. They sought AlvaMed's expertise to develop a comprehensive clinical strategy, obtain IRB approval, and secure a study-ready site. 𝐎𝐮𝐫 𝐀𝐩𝐩𝐫𝐨𝐚𝐜𝐡: AlvaMed provided comprehensive support, including: • 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗣𝗹𝗮𝗻𝗻𝗶𝗻𝗴: Developed a streamlined clinical strategy to minimize timelines and maximize efficiency. • 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁: Created a comprehensive protocol and supporting documentation and implemented a full suite of clinical study SOPs. • 𝗦𝗶𝘁𝗲 𝗟𝗲𝘃𝗲𝗹 𝗖𝗼𝗻𝘁𝗿𝗮𝗰𝘁𝗶𝗻𝗴 & 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁: Negotiated and executed a clinical trial agreement in under 2 months. • 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆: Obtained IRB approval with a Non-Significant Risk designation, expediting the study start-up process. 𝐓𝐡𝐞 𝐑𝐞𝐬𝐮𝐥𝐭: We successfully delivered a compliant and executable clinical study plan, enabling our client to accelerate their development timeline and achieve their clinical goals. The client was able to rapidly initiate their clinical study, saving valuable time and resources. Read the full case study here: https://lnkd.in/eK4kXb7V Contact us to learn how AlvaMed can help you achieve your clinical research objectives. #MedicalDevices #ClinicalTrials #RegulatoryAffairs #CRO #RegulatoryStrategy #ClinicalStrategy

During the busy holiday season, we were able to find some time to celebrate with some of our local AlvaMed team members. The snowy weather made it a truly memorable gathering. As we head into the new year, we’re energized and excited to help our clients achieve their goals! Here’s to a successful and rewarding year ahead! Mark Cox Eric Bannon Jon Saltonstall Marc Quartulli Diana Grenier Abbie Banjak Merson Rupali Kumar

𝐇𝐚𝐩𝐩𝐲 𝐍𝐞𝐰 𝐘𝐞𝐚𝐫 𝐟𝐫𝐨𝐦 𝐀𝐥𝐯𝐚𝐌𝐞𝐝! As we embark on a new year, we're excited to continue our partnership with you and help drive innovation in the medical device industry. We're committed to providing you with the regulatory, quality, and clinical research services to ensure your success. Wishing you a prosperous and successful 2025!

Wishing you a joyful holiday season and a successful 2025! Cheers to new opportunities and continued success together. We are grateful for our partnerships and the successes we’ve shared with our clients. We’re excited to continue supporting your goals in the year ahead.

The Canadian Artificial Intelligence and Data Act The Canadian Artificial Intelligence and Data Act (AIDA) aims to establish a robust framework for ethical AI development and deployment. This legislation seeks to balance innovation with protection of individual rights, ensuring responsible use of AI while fostering economic growth. Read more here: https://lnkd.in/e7TfXG5Y #medicaldevices #AIDA #ai

European Commission’s Guidance for Joint Clinical Assessments The European Commission has released a guide on the validity of clinical studies for Joint Clinical Assessments (JCAs). This initiative aims to harmonize the assessment of new health technologies, improving patient outcomes and streamlining decision-making across member states. Read more here: https://lnkd.in/eyv_Wv7d #medicaldevices #medtech #HTAR #JCA