DQS

When does software qualify as a medical device under the EU MDR? As healthcare technology continues to evolve, the line between software and medical devices is becoming increasingly important — and highly regulated. Understanding when software qualifies as a medical device under the EU MDR, and what it takes to achieve certification, is critical for manufacturers navigating compliance, patient safety, and market access. This insightful article breaks down the key considerations around Medical Device Software (MDSW), MDR certification pathways, and the growing impact of software in modern healthcare innovation. Read more: https://lnkd.in/d95VrEUY #MedicalDevices #MDR #SoftwareAsAMedicalDevice #SaMD #HealthcareTechnology #RegulatoryCompliance #DigitalHealth #MedicalDeviceSoftware #DQS

Thanks for this Dr. Thijs Willaert , the Responsible Business Alliance has great events with practical meaningful content. Thanks for the open knowledge sharing!

Yesterday was a great day for anyone working on the implementation of CSDDD - thank you Responsible Business Alliance , EPP Group in the European Parliament and Business Europe for an insightful conference in the heart of Brussels. One of the key discussions was around legal certainty: we all want it, and we are unlikely to get it (soon). The guidelines from the European Commission will have to strike a balance clarity and flexibility. My personal thoughts: we are expecting too much from these guidelines and we should not wait for their publication, as they will be fully aligned with OECD guidelines, for which there is plenty of supporting material, courses, webinars, ... already. At DQS we keep working to ensure our audit services support, and are aligned with, due diligence regulation. #csddd #cs3d #hredd #dqs #onedqs

Headline: A Landmark Moment for Indian Maritime Sovereignty: IRQS Welcomes the ‘Bharat Maritime Insurance Pool’ 🚢🇮🇳 At IRQS, we are thrilled to witness a historic shift in India's maritime landscape. The Union Cabinet’s approval for the creation of the Bharat Maritime Insurance Pool (BMI Pool), backed by a significant sovereign guarantee of ₹12,980 Crore, marks a definitive step toward Atmanirbharta (Self-Reliance) in the shipping sector. For decades, the Indian shipping industry and exporters have been heavily dependent on international P&I clubs—primarily based in the UK and Europe—for insurance coverage. This dependency often left our trade vulnerable to global geopolitical shifts, sanctions, and volatile premium spikes. Why this matters for the Industry: Operational Sovereignty: By moving away from exclusive reliance on foreign insurers, Indian shipping gains the autonomy to operate even during global uncertainties. Boost to Exports: Affordable and continuous insurance coverage will significantly lower the cost of trade, opening new doors for Indian exporters to reach global markets with confidence. Comprehensive Protection: The pool will cover essential risks including Hull & Machinery, Cargo, Protection & Indemnity (P&I), and even War Risks. Domestic Expertise: This initiative will foster specialized marine underwriting and claims management expertise within India, strengthening our maritime ecosystem. We extend our heartfelt gratitude to the Government of India and the Ministry of Shipping for this visionary move. As a body dedicated to quality and excellence in the maritime and industrial sectors, IRQS is excited to support the industry as it navigates this new era of growth and stability. Here is to a more resilient, sovereign, and globally competitive Indian Maritime sector! https://lnkd.in/gVuyzZ8Y ⚓ #IRQS #ShippingIndustry #MaritimeIndia #BharatMaritimeInsurancePool #AtmanirbharBharat #IndianExports #BlueEconomy #ShippingNews #CabinetApproval