DQS’ Post

🔒 Did you know? On average, a new Cyber Security attack is launched every 3 seconds - that's over 26,000 attacks per day targeting businesses worldwide. In a world where digital threats are ever-present, organizations must stay one step ahead. This October, DQS is celebrating Cyber Security Awareness Month by helping businesses strengthen their defenses. From TISAX® and VCS for automotive security to ISO/IEC 27001 for comprehensive information security management, our certifications ensure your systems are fortified and compliant against evolving threats. Discover how DQS can help strengthen your Cyber Security framework: https://lnkd.in/eR2XSUjv Stay tuned for more updates, blogs and expert insights on how you can improve your Cyber Security strategy with DQS during the #CyberSecurityAwarenessMonth. Let's make Cyber Security a priority together. #DQS #Cybersecurity #DataProtection #TISAX #ISO27001

Is regulatory complexity holding back your market expansion? Check out our new blog article: 🚀 Post-Market Surveillance and Vigilance: Requirements for MDSAP For medical device manufacturers, Post-Market Surveillance (PMS) under the Medical Device Single Audit Program (MDSAP) isn’t just about ticking boxes- it’s about gaining global market access with efficiency. In our latest blog, we break down how PMS under the MDSAP framework can simplify compliance and open doors to global markets for medical device manufacturers. 💡 Why Read This Blog? - Learn how one audit can meet regulatory requirements for multiple markets: U.S., Canada, Japan, Australia, and Brazil. - Discover how PMS can help you manage risks more effectively, keeping your devices compliant and competitive. - Explore how streamlined PMS processes can lead to faster approvals and improved market access. This article is packed with insights on how PMS and MDSAP can boost efficiency and market reach. If you're looking to grow internationally, you won’t want to miss it! Read the full article here: https://lnkd.in/d6vnvABs #MDSAP #PMS #MedicalDevices #MarketAccess #RegulatoryCompliance #GlobalMarkets Sigrid Uhlemann Heinrich von Mettenheim Szymon Kurdyn Michael Bothe Sabine Müller Yuan Li, PhD Carrie Beth Johnson George Bell Scott Adams Jessica Giles

We are proud to announce that DQS has certified Hyundai MOBIS as the first automotive supplier outside Europe to achieve the ENX Vehicle Cyber Security (VCS) certification! Developed in collaboration with ENX, the VCS standard establishes a globally harmonized framework for Cyber Security management in the automotive industry, aligning with UNECE R155 requirements.  Having previously certified Hyundai Mobis for TISAX®, we are thrilled to continue our partnership and support their commitment to global cybersecurity standards. 🔗 Read more about this achievement here: https://lnkd.in/ezbUhR59 #CyberSecurity #Automotive #VCS #DQS #HyundaiMobis #TISAX #ENX #GlobalStandards

We're excited to announce a special collaboration between Easy Medical Device and DQS (German notified body # 0297). Check out our podcast here: https://lnkd.in/eW-gbhN5 Join us as we dive into the key aspects of medical device market access in the EU and US (with some insightful commentary on the UK landscape as well).   This podcast serves as an introduction to a new blog series by DQS that will be published over the coming weeks. We’ll break down the critical differences, requirements, and regulatory pathways for entering these two major global markets.   You’ll learn about: - The key regulatory frameworks in the EU and US - Essential steps for gaining market access - The importance of planning Whether you're looking to expand into these markets or stay updated on the latest regulatory trends, this podcast is packed with valuable insights! Stay tuned for deeper dives in our upcoming blogs. If you require certification services for your medical devices, please contact us here: https://lnkd.in/dK_FsN-K #medicaldevices #regulatory #mdr #fda #fdaclearance #medicaldevicecertification #audit Sigrid Uhlemann Heinrich von Mettenheim Sabine Müller Szymon Kurdyn Michael Bothe Yuan Li, PhD Lisa Brandon Carrie Beth Johnson Scott Adams Jessica Giles Jaques Terblanche George Bell Stefan Hofmann Amsal Alihodzic

🌍 How Medical Device Regulations Are Shaping Global Markets 🚀 What’s changing with Europe’s MDR and how does it differ from the FDA in the USA? Our article explores: 🔑 Key differences between MDR and FDA 🌐 Opportunities to streamline approval across global markets 📈 Leveraging ISO 13485 and MDSAP for faster market entry 🎯 The strategic edge of CE marking for international expansion Read the full breakdown of global regulatory opportunities: https://lnkd.in/dUV_Vmxw #MedicalDevices #MDR #FDA #MedTech #RegulatoryCompliance #ISO13485 #CECertification #HealthcareInnovation Sigrid Uhlemann Heinrich von Mettenheim Michael Bothe Szymon Kurdyn Yuan Li, PhD Lisa Brandon Carrie Beth Johnson Francois Labuschagne Scott Adams Jessica Giles Sabine Müller Gianluca Nasi

🌐 Looking to streamline your supplier management and purchasing process for medical device manufacturing? Check out our latest article on the MDSAP Audit Approach and how it can enhance your supplier selection process! 🔍 From key evaluation criteria to ongoing re-evaluations, we cover how MDSAP builds on ISO 13485 to ensure compliance across multiple jurisdictions, saving time, reducing costs, and maintaining the highest standards. 📄 Read more here: https://lnkd.in/g77y5fk8 #MDSAP #MedicalDevices #SupplierManagement #ISO13485 #RegulatoryCompliance #Audit Sigrid Uhlemann Heinrich von Mettenheim Sabine Müller Szymon Kurdyn Michael Bothe Gianluca Nasi Yuan Li, PhD Lisa Brandon Carrie Beth Johnson Scott Adams Jessica Giles Mahantesh Dhabe Jaques Terblanche

According to the World Economic Forum, the healthcare sector experienced an average of 1,684 cyberattacks per week in 2023, representing a 22% increase compared to the previous year. This makes the healthcare industry one of the most targeted sectors globally. This highlights the growing urgency of taking cybersecurity seriously in medical devices. Medical devices must not only be protected from digital threats but also ensure that they function reliably and correctly in all operating conditions. This is especially important for medical products used in diagnosis and therapy. Integrating these security aspects is crucial to ensuring the safety of patients and users. The experts at DQS support your company in meeting essential requirements, thereby minimizing risks for your company, products, patients, and users. We offer certifications according to ISO 13485 for quality management systems in medical technology and ISO 27001 for information security management. Contact us to learn more about how we can assist you: ISO 13485: https://lnkd.in/dWXYie_Z ISO 27001: https://lnkd.in/gcycZZtK Stay informed about the latest developments in this critical area and how you can adapt your security strategies. Sigrid Uhlemann Heinrich von MettenheimSabine Müller Gianluca Nasi Michael Bothe Szymon Kurdyn Carrie Beth Johnson Yuan Li, PhD Scott Adams Jessica Giles George Bell Jaques Terblanche Francois Labuschagne Karin Yang #ISO #Cybersecurity #Certification #Regulatory #Medicaldevices