AtriCure, Inc.’s Post

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📢 A big 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 to Peter Ratcliffe, PhD for identifying unfinished text on Page 5. 𝗥𝗲𝘃𝗶𝘀𝗶𝗼𝗻 𝟭: 📌𝗔 𝗕𝗿𝗶𝗲𝗳 𝗚𝘂𝗶𝗱𝗲 to 𝗗𝗲𝘀𝗶𝗴𝗻 𝗖𝗼𝗻𝘁𝗿𝗼𝗹𝘀 / 𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗥𝗲𝗮𝗹𝗶𝘇𝗮𝘁𝗶𝗼𝗻. from MedTech Leading Voice 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗥𝗼𝘂𝗻𝗱𝘂𝗽 💠 Here's what is covered: The fundamentals of design controls and how they influence the entire product lifecycle, from device development to post-market surveillance. 🔎 𝙈𝙚𝙚𝙩𝙞𝙣𝙜 𝙁𝘿𝘼 𝙖𝙣𝙙 𝙄𝙎𝙊 𝙧𝙚𝙜𝙪𝙡𝙖𝙩𝙤𝙧𝙮 𝙧𝙚𝙦𝙪𝙞𝙧𝙚𝙢𝙚𝙣𝙩𝙨 💡 𝘽𝙚𝙨𝙩 𝙥𝙧𝙖𝙘𝙩𝙞𝙘𝙚𝙨 𝙛𝙤𝙧 𝙙𝙚𝙨𝙞𝙜𝙣 𝙫𝙚𝙧𝙞𝙛𝙞𝙘𝙖𝙩𝙞𝙤𝙣 𝙖𝙣𝙙 𝙫𝙖𝙡𝙞𝙙𝙖𝙩𝙞𝙤𝙣 📁 𝙈𝙖𝙣𝙖𝙜𝙞𝙣𝙜 𝙙𝙚𝙨𝙞𝙜𝙣 𝙝𝙞𝙨𝙩𝙤𝙧𝙮 𝙛𝙞𝙡𝙚𝙨 𝙖𝙣𝙙 𝙙𝙚𝙨𝙞𝙜𝙣 𝙩𝙧𝙖𝙣𝙨𝙛𝙚𝙧 🛠️ 𝙏𝙝𝙚 𝙧𝙤𝙡𝙚 𝙤𝙛 𝙙𝙚𝙨𝙞𝙜𝙣 𝙧𝙚𝙫𝙞𝙚𝙬𝙨 𝙖𝙣𝙙 𝙘𝙝𝙖𝙣𝙜𝙚 𝙘𝙤𝙣𝙩𝙧𝙤𝙡𝙨 Whether you're involved in quality assurance, product development, or regulatory compliance, this 𝗕𝗿𝗶𝗲𝗳 𝗚𝘂𝗶𝗱𝗲 will offer valuable insights and a useful training deck, into achieving success in the medical device industry. This brief guide follows-on from 𝗔 𝗕𝗿𝗶𝗲𝗳 𝗚𝘂𝗶𝗱𝗲 𝘁𝗼 𝗨𝘀𝗲𝗿 𝗡𝗲𝗲𝗱𝘀 𝗔 𝗕𝗿𝗶𝗲𝗳 𝗚𝘂𝗶𝗱𝗲 𝘁𝗼 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗜𝗻𝘁𝗲𝗻𝗱𝗲𝗱 𝗨𝘀𝗲 𝗔 𝗕𝗿𝗶𝗲𝗳 𝗚𝘂𝗶𝗱𝗲 to 𝗗𝗲𝘀𝗶𝗴𝗻 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗣𝗹𝗮𝗻 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 for 𝘆𝗼𝘂𝗿 time and please 𝗟𝗶𝗸𝗲 👍, 𝗦𝗵𝗮𝗿𝗲, and/or 𝗖𝗼𝗺𝗺𝗲𝗻𝘁 #medicaldevices #invitrodiagnostics #combinationproducts #mlv #qualityassurance #regulatoryaffairs #pharmaceuticals

Do you know the following sentence? "Design validation shall be conducted on representative product. Representative product includes initial production units, batches or their equivalents. The rationale for the choice of product used for validation shall be recorded". For sure you do, or? It's from clause 7.3.7 in ISO 13485:2016. If you are involved in engineering of medical devices, please be reminded to adhere to this requirement. By the way, it applies as well to PQ in the area of process validation. In each of my last three audits I came across one violation in those areas: Non-equivalent design validation lots, PQ having been done with early prototypes or even commerical products not being representative.

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🔍 Exploring the Vital Role of Packaging Engineers in Medical Device Manufacturing 📦💡 Packaging Engineers are the unsung heroes in ensuring the safety, efficacy, and compliance of medical devices. Their meticulous work spans from designing robust packaging solutions to executing critical validation processes that uphold product integrity throughout its lifecycle. Key responsibilities include: ✅ Developing and optimizing packaging designs that meet regulatory standards. ✅ Conducting rigorous testing and validation to ensure packaging durability and sterility. ✅ Collaborating with cross-functional teams to integrate innovative solutions and streamline processes. ✅ Managing risk assessments and implementing corrective actions to enhance packaging quality. ✅ Supporting continuous improvement initiatives to drive efficiency and cost-effectiveness. In the dynamic landscape of medical device manufacturing, Packaging Engineers play a pivotal role in safeguarding patient safety and product quality. Let's recognize their dedication to excellence and innovation in healthcare delivery! 🌟 #PackagingEngineer #MedicalDevices #QualityAssurance #InnovationInHealthcare #MedicalDeviceManufacturing #HealthcareEngineering #RegulatoryCompliance

---Verification & Validation--- --Verification and validation are design controls required to ensure the medical devices you manufacture are safe, effective and fit the intended use. --Verification is a quality control process that checks whether your design meets the specifications you laid out in your product development specification (PDS). --Validation, on the other hand, is a process that checks if the device or components fulfills the intended use and user requirements. Validation typically involves evaluating the finished device to see if it meets the user requirements. --While verification and validation are related, they are different activities with different goals and are typically performed at separate times during the development process. There are five main differences between verification and validation: -Purpose: Verification proves the manufacturing process produces the correct product. Validation proves that the product works as intended. -Timing: Verification is typically performed during development, while validation happens after product development. -Methods: Verification occurs through reviews, inspections, and bench testing that do not involve real-world testing. Validation involves using the product and evaluating its performance in a live environment. -Output: Verification activities produce outputs such as review and inspection reports. Validation activities produce outputs such as test and acceptance reports. -Responsibility: Verification is typically the development team’s responsibility, while validation is the responsibility of an independent testing group. #verification_validation #VandV #MedicalDeviceinsights

What’s the difference between Verification and Validation in Medical Device Design and Manufacturing? In my opinion, it's the key to solving the complex regulatory cycle of any medical device development. At Johari Digital Healthcare Limited, we don’t just check boxes and we ensure that both Verification and Validation are embedded into our products and processes. And believe me, it hasn’t been an easy journey. Working with multiple OEM clients in the Medical Device Industry has taught us valuable lessons: • We’ve faced setbacks during verification. • We’ve worked long hours to meet validation standards. • We’ve refined manufacturing to align perfectly with intended use. In the moment, these felt like hurdles. But when we step back, we realize these challenges were actually lessons in disguise. Here’s the biggest takeaway: Let: • Verification become a thorough check. • That thorough check become early issue detection. • Early detection lead to fewer setbacks. • Fewer setbacks become smoother processes. • Smoother processes lead to better products. • And better products build trust in your business. We repeat this cycle of improvement consistently with every OEM partner. Ready to ensure your devices meet the highest standards? 📌 Let’s connect: https://lnkd.in/ezN3mRUd #MedicalDevice #VerificationAndValidation #MedicalManufacturing #QualityControl #HealthcareInnovation

Design transfer is a critical phase in medical device development. 🔑 Key Documents 1️⃣ Design History File (DHF) Contains all design-related documentation. Demonstrates the design was developed in accordance with the approved design plan. 2️⃣ Device Master Record (DMR) Includes device specifications, production processes, quality assurance, and labeling. Ensures the device is produced consistently. 3️⃣ Risk Management File Documents risk analysis and mitigation strategies. Essential for demonstrating product safety and effectiveness. 4️⃣ Verification and Validation (V&V) Reports Confirm the design meets the requirements. Include test results, protocols, and acceptance criteria. 5️⃣ Design Review Records Minutes and actions from design reviews. Provide evidence of systematic evaluation throughout the design process. 6️⃣ Change Control Records Detail any design changes. Maintain traceability and rationale for modifications. 7️⃣ Supplier and Component Documentation Ensures all parts meet specified requirements. Includes supplier qualifications and component specifications. 8️⃣ Training Records Proof that personnel involved in design transfer are trained. Ensures proper understanding and execution of processes. 📝 Signatures Needed Project Manager → Confirms project completion and readiness for transfer. Quality Assurance (#QA) → Verifies compliance with regulatory and quality standards. Regulatory Affairs (#RA) → Ensures all regulatory requirements are met. Engineering Lead → Validates the technical aspects of the design. Manufacturing Representative → Confirms manufacturability of the design. Risk Management Lead → Verifies risk controls are in place. Ensuring thorough documentation and proper sign-offs mitigates risks and supports compliance. Streamline your design transfer with these essentials for a smooth transition. Follow for daily insights into tech product development. #MedicalDevices #ISO13485 #21CFR820 #QualityAssurance #RegulatoryCompliance #SimplifyingInnovation #Unplex

🔬👨🔬🌐 At TS Quality & Engineering, we are proud to showcase the strength and expertise of our incredible team. Our team comprises dedicated engineers and subject experts who have accumulated a wealth of experience in the Medical Device field. This expertise allows us to swiftly determine the optimal approach for each project, ensuring we deliver top-tier solutions for our clients. The combination of our deep knowledge of the regulatory landscape, understanding of international standards, and hands-on experience with industry-leading companies empowers us to optimize development processes, navigate challenges and deliver excellence consistently. By leveraging our team's diverse skills and experiences, we are committed to continuing our mission of advancing the medical device industry. Do you want to learn more about how we can support your projects? Reach out - we're always excited to discuss how our expertise can align with your goals. #TSQualityAndEngineering #MedicalDevices #EngineeringExcellence #Teamwork #IndustryLeaders #RegulatoryCompliance #InternationalStandards #medicaldevice #projects #engineers #engineering #development"