DQS’ Post

Especially interesting for newcomers to the medTech sector. Not everyone wants to become a manufacturer of medical devices within the definition of the MDR. For many companies in the supply and service industry, certification in accordance with ISO 13485 is the first step. Let's talk about it!

📢 ISO 13485:2016 Survey Now Open! 📢 ISO - International Organization for Standardization are seeking YOUR feedback on the use of the international standard, ISO 13485:2016 “Medical devices – Quality management systems – Requirements for regulatory purposes”. 🩺 Their aim is to assess stakeholder needs with respect to regulatory use, and determine the positive or negative impacts of a possible revision. 🩺 The survey can be accessed online at https://lnkd.in/ekrAEAzS and should take no longer than 20 minutes to complete. #MedicalDevices #ISO13485

How to Fulfill Management Responsibilities in ISO 13485:2016? Read more: https://lnkd.in/eSKuxh2P In this comprehensive guide, we cover: 1) Overview of ISO 13485:2016: Get a refresher on the key elements of the ISO 13485 standard and its significance in the medical device industry. 2) Management Responsibilities Defined: Explore the specific management responsibilities outlined in ISO 13485:2016 and understand their impact on your organization's quality management system. 3) Best Practices for Compliance: Gain practical insights and strategies for effectively fulfilling management responsibilities to ensure compliance with ISO 13485:2016. Don't miss out on valuable insights! Follow our LinkedIn page to stay updated with the latest blog posts, industry news, and exciting updates from Kelmac Group®. #iso13485 #medicaldevices #management #qualitymanagement

Hey there, it's time for another quick dive into the world of quality management with Darren Reeves. Today, we're tackling comment No. 12 from the QMSR Preamble, a seemingly straightforward yet crucial topic: the dissemination of information. Some folks suggested that the FDA keep certain paragraphs from the QS Regulation in effect, specifically regarding CAPA. These sections play a vital role in ensuring quality and addressing nonconformities effectively. The FDA recognizes the importance of this topic, and wants to ensure the essence of these provisions is captured. Watch the video for more details on the concerns expressed and the FDA’s response about adequate dissemination of information to those responsible for maintaining the quality of a medical device. For more quality management wisdom, visit us at dpdconline.com and join the conversation on LinkedIn. Stay curious, stay quality-conscious. Let's keep learning and improving together. #CAPA #QualityManagementSystem #QMSR #ISO13485 #DPMinutes #QSRegulation #DPDConsulting #MedicalDeviceConsultation #MedicalDeviceRegulation 

So important to understand the interaction between specific wording, and the spirit of what is being conveyed...Darren Reeves explains this about comment #12 in the QMSR Preamble in the video below:

🚀 Special Offer Alert: ISO 13485 Templates Bundle at QMSREGS.com! 🚀 Are you looking to streamline your medical device quality management system? QMSREGS.com has an unbeatable offer just for you! Get our full bundle of ISO 13485 templates for only £399.99, usually priced at £699.99! 🌟 Why Choose Our ISO 13485 Templates Bundle? 🌟 🔍 Comprehensive Coverage: Our templates cover all aspects of ISO 13485 requirements, ensuring you have everything you need for compliance. ✅ Simplified Compliance: Easily navigate the complexities of ISO 13485 with our expertly crafted templates, designed to make your compliance journey smooth and straightforward. 📈 Boost Efficiency: Save time and resources with pre-made templates that are easy to customize and implement, enhancing your operational efficiency. 💡 Expertly Developed: Created by industry professionals with extensive experience in ISO 13485, our templates provide you with reliable and high-quality tools. 💰 Unbeatable Value: Take advantage of this limited-time offer and get the complete bundle for only £399.99, down from the regular price of £699.99. That's over 40% in savings! Don't miss out on this incredible deal to elevate your quality management system and ensure compliance with ISO 13485. 🔗 Explore more and get your bundle today at QMSREGS.com 🔗 #ISO13485 #QualityManagement #MedicalDevices #Compliance #SpecialOffer #Templates #QMSREGS #OperationalExcellence

https://lnkd.in/gSgcCuEJ (13485 Store & QMSR Checklist) I thought this would be a good time to post once more this very popular General Guide to ISO 13485:2016 Quality Management Systems. I figured it could also potentially be useful to those companies that need to make the transition to the QMSR. Anyone who would like a copy just email me at address below. For some medical device companies this will be a significant change and to start understanding potential gaps its always essential to begin with a complete gap analysis. Available for download from our 13485 Store we have a 41 page comprehensive QMSR gap analysis checklist. (see link above) Also until the end of this April I am including an offer with the checklist download, and to help fill potential QMS/QMSR documentation gaps, 3 document templates at no charge. If interested and after your download, you can email me for details at [email protected] #iso13485 #fdaqmsr #qualitymanagement #medicaldevices

Its easier to understand than ever before.

While procedures are critical, it is vitally important to ensure that one knows how to locate and prove with objective evidence that the quality system is meeting the stated requirements.

😃 Our very own QRx Partner Mark Swanson published a white paper with BSI Compliance Navigator for Medical Devices. Scroll for a snippet as well as the link to the full download ... 👏 🗨 "ISO 9001 was first published in 1987 and then revised to a second edition in 1994. Meanwhile the initial versions of the QMS standard for medical devices was published as part of the ISO 46000 series which later became the first edition of ISO 13485 (along with ISO 13488) in 1996. In 2000, the third edition of ISO 9001 was published and ISO 13485 was revised in 2003 to align with that revision (ISO 13488 was withdrawn at this time). In 2008, ISO 9001 was again revised and brought in many of the requirements of ISO 13485:2003. It was decided (by international ballot) in the periodic review that no corresponding revision of ISO 13485 was to be done." 👉 Read the full white paper, written by Mark Swanson, Partner & CEO, QRx Partners, to find out the differences between the two standards in: •  Structure •   Scope •   Focus •   Required Processes •   Personnel Identification •   Product Realization •   Continual Improvement •   Terminology Download the full white paper here 👉 https://lnkd.in/gSU9y-9E #QRxPartners #QRxInforms #mlv #compliance #iso90012015 #iso13485 #medicaldevices #regulatory #standards #askanexpert