Mario Wijker

FDA recalls have significantly increased over the last six years and the 🔑 to avoiding one is staying on top of quality management. Learn more about some key components of product recall avoidance in MasterControl's guide here: https://lnkd.in/e_ZhWVxr #drugrecalls #qualitymanagement #lifesciences #FDA

8

#medicaldevices #iso14971 #riskmanagement 📄"At its core, ISO 14971:2019 outlines a risk management framework that supports manufacturers in identifying, evaluating, and mitigating risks associated with medical devices, including software as a medical device (SaMD)", writes Noa Mizrachi. Following an excellent week in Phoenix for the Health-ISAC Americas US Summit, Noa provides a primer on the standard that's shaping risk management in the medical devices sector.🥼 🔗 Read Noa's full commentary on our blog: https://lnkd.in/dTdANJ_k #productsecurity #cybersecurity #sbom #contextdriven

13

1 Comment

PI's Krystal Santiago (VP Regulatory Affairs) discusses the shift towards point-of-care diagnostics and its drive to reduce test times while meeting stringent regulatory standards. Learn more about PI's regulatory expertise here: https://lnkd.in/dZKT6g2n #FDA #productdevelopment #regulatoryadvice #regulatorystrategy #regulatorystandards

39

Did you know that in January of this year, the FDA published its long-anticipated final rule to amend its existing medical device good manufacturing practice (CGMP) expectations under the Quality System Regulation (QSR) 21 CFR Part 820 with the internationally recognized standard ISO 13485:2016? In this blog post, you'll learn all about this final rule, what it implicates for manufacturers and how the QbD Group can help you to become compliant with the QMSR. 📄✔️ 👉 https://hubs.li/Q02xc7SZ0 #ISO13485 #QSR #QMSR #CGMP

14

1 Comment

Did you know that in January of this year, the FDA published its long-anticipated final rule to amend its existing medical device good manufacturing practice (CGMP) expectations under the Quality System Regulation (QSR) 21 CFR Part 820 with the internationally recognized standard ISO 13485:2016? In this blog post, you'll learn all about this final rule, what it implicates for manufacturers and how the QbD Group can help you to become compliant with the QMSR. 📄✔️ 👉 https://hubs.li/Q02xc9Xk0 #ISO13485 #QSR #QMSR #CGMP

12

Is it time to re-evaluate your CAPA processes? If your CAPA management isn't up to par, you could get cited by the FDA. Inefficient CAPAs are one of the most common reasons companies receive Warning Letters. Take a look at these strategies for ensuring you have successful CAPA management. Audit your CAPA process with OQSIE. Contact us for a free quote: www.oqsie.com/contact #capa #lifesciences #qualitymanagement

2

🌟 Elevating Medical Device Quality Systems: Key Insights from FDA Observations 🌟 From retrieving five years’ worth of medical device FDA observations, patterns emerged. The ten elements of a medical device quality system referenced most (keyword search) in the last five years of FDA observations worldwide are: 💻 CAPA: Corrective and Preventive Action (CAPA) processes are critical for identifying and addressing non-conformities. Effective CAPA ensures that underlying issues are not only corrected but also prevented from recurring, maintaining the integrity of the quality system. 🔬 Product Safety: Ensuring product safety is paramount. This involves rigorous risk management practices, continuous monitoring, and adherence to safety standards to protect patients and end-users from potential hazards associated with medical devices. 📓 Process Validation: Rigorous validation processes are the cornerstone of ensuring that every step in medical device manufacturing is validated to meet quality standards. 📒 Procedures: Well-defined and documented procedures lay the foundation for consistent processes, ensuring adherence to regulatory requirements and product quality. 🔍 Investigations: Thorough investigations into deviations or discrepancies are crucial for identifying root causes and implementing corrective actions to prevent recurrence. 🖋 Data Integrity: Upholding data integrity principles ensures the accuracy, completeness, and reliability of data throughout the product lifecycle. 📐 Design Controls: Robust design controls ensure that medical devices meet user needs and intended uses. This involves meticulous planning, design verification and validation, and documentation throughout the product development process. 🌍 Environmental Monitoring: Monitoring and controlling environmental conditions within manufacturing facilities are essential to prevent contamination and maintain product integrity. 📏 Calibration: Regular calibration of equipment is necessary to ensure that instruments and devices are performing accurately and consistently, thereby ensuring the reliability of test results and measurements. 🏫 Training: Continuous training programs for staff are vital to maintaining a high level of competence and awareness of regulatory requirements, quality standards, and best practices within the medical device industry. Over the next weeks, we will be sharing deeper insight into these top 10 FDA observation elements. 📧 Comment or like if you would like to discuss further. #qualitysystem #FDA #meddevice #continuousimprovement

A successful transition from FDA's QSR to QMSR is critical for medical device manufacturers. ELIQUENT Life Sciences' new QMSR service offering, backed by ELIQUENT's unprecedented assembly of regulatory leaders, industry experts, and technical specialists, guides medical device manufacturers to a smooth and successful adoption of the new regulatory framework. Learn more about ELIQUENT's QMSR solutions at https://lnkd.in/eYy5b2_m

10

FDA’s transition from QSR to QMSR is quickly approaching...ELIQUENT Life Sciences is uniquely positioned to support organizations during this critical transformation. The firm's new QMSR service offering, backed by a team of best-in-class experts, guides medical device manufacturers to a smooth and successful adoption of the new regulatory framework. Learn more about ELIQUENT's QMSR solutions at https://lnkd.in/eYy5b2_m

3

CAPA compliance isn’t optional — it’s essential. The FDA expects robust Corrective and Preventive Action (CAPA) processes to ensure quality and patient safety. Our blog explores a real-world approach to maintaining CAPA standards, avoiding pitfalls, and ensuring long-term compliance. Don’t let gaps in your CAPA process lead to costly consequences. Read the blog here: https://lnkd.in/eQ9z96E8.

22

1 Comment

Market Pathways a comprehensive visual overview of the #FDA's Predetermined Change Control Plan (PCCP) program and the device modifications it has supported to date. Explore key statistics and insights into the FDA's use of PCCPs to facilitate #regulatory flexibility in medical device development: https://bit.ly/3MYv55d

1

AI is revolutionizing GxP validation in life sciences, but success requires more than just implementing new tools. The real transformation happens when AI enhances your existing validation strategy, not replaces it. See how leading organizations are using AI to strengthen their validation processes by: - Automating documentation while maintaining data integrity - Enhancing risk assessment with predictive analytics - Accelerating review cycles without compromising quality - Building scalable validation frameworks that evolve with technology Ready to see where AI fits in with your validation roadmap? Learn more by visiting our website. https://lnkd.in/ejEpvAb4 #AI #lifesciences #qualitycontrol #GxP #pharma #compliance #digitaltransformation

11

💥26th May 2024 is the first important deadline for MDR transition 💥 If you manufacture legacy devices and want to continue under MDR, you only have SIX DAYS to make sure your MDR transition happens. You won't be able to switch your device over and keep it on the market if these dates are missed. 🔴BY 26 MAY 2024🔴 - Your QMS must be MDR compliant. - You must send a written assessment application to a Notified Body. 🔴BY 26 SEPTEMBER 2024🔴 - Your MDR Agreement must be signed with the Notified Body. MDD legacy devices have far more conformity routes to choose from versus devices who do not have MDD CE mark. CLIN-r+ can still help! Book a meeting with us NOW 👉 https://loom.ly/S43Wxj4

2

Even thought the effective date of enforcement for the QMSR is Feb. 2, 2026 it is never to early to start preparing if you are in the #medicaldevice profession. BTW, this will be one of the main topics at the upcoming Innovate for Excellence Summit - Chicago.

1

1 Comment

The FDA has been rolling out changes with the new QMSR (Quality Management System Regulation), and there's been a lot of discussion around what it all means. If anyone still has questions, the 𝗙𝗗𝗔 𝗵𝗮𝘀 𝗷𝘂𝘀𝘁 𝘂𝗽𝗱𝗮𝘁𝗲𝗱 𝘁𝗵𝗲𝗶𝗿 𝗙𝗔𝗤 on the topic to provide more clarity. You can check it out here: 👉 https://lnkd.in/e5N78dBs On top of that, for those looking to dive deeper into the differences between the old QSR and the new QMSR, 𝘄𝗲’𝘃𝗲 𝗴𝗼𝘁 𝗮 𝗱𝗲𝘁𝗮𝗶𝗹𝗲𝗱 𝗰𝗼𝗺𝗽𝗮𝗿𝗶𝘀𝗼𝗻 𝘁𝗮𝗯𝗹𝗲 available for download. It also highlights how ISO 13485 fits into the equation. 👉 https://lnkd.in/eESmKAtR Between these resources, you should have everything needed to stay on top of the latest regulatory updates! #FDA #QMSR #ISO13485 #RegulatoryUpdates #MedicalDevices

3

New draft guidance from FDA on defining and reporting protocol deviations. FDA regulations do not currently include a definition of the term protocol deviation or provide a system for classifying the various types of deviations that may occur during the conduct of a clinical investigation. This guidance may move industry closer to a system that applies consistent classification, reporting, and documentation standards is important to assure the most interpretable and useful information emerges from the reporting of protocol deviations. Open comment period through February 2025 for Sponsors, investigators and IRBs. Let your voice be heard! #clinicalstudies #clinicaltrials #pharma #clinicalresearch #biopharma https://lnkd.in/gWE_v5xx

9

MDRChats by ChatMDR is back: Conformity Assessment Route under the MDR! In this episode, we dive into the key differences in conformity pathways for medical devices. #MDRChats #ChatMDR #MedicalDeviceRegulation #ConformityAssessment #RegulatoryAffairs #Compliance

6