🎄 Oh! Jingle bells, jingle bells, jingle all the way… straight into family chaos. The most wonderful time of the year is upon us. And with it, perhaps the most exhausting time as well. Along with all the gift shopping, cookie baking, and tree decorating, the not-always-so-peaceful family gatherings usually make their annual appearance. But fear not! As a MedTech expert, you have all the necessary tools and skills to survive this holiday season unscathed with the help of our Christmas Chaos CAPA Management Guide, by Deborah L. Rossier-Morgenthaler, Head of Quality & Engineering and QMR. #medicaldevices #qualitymanagement #capa #medtech
ISS AG, Integrated Scientific Services
Medizintechnik
Professional support for MedTech companies: Medical Devices & IVD Regulatory Compliance
Info
ISS AG is your trusted partner in the MedTech industry, offering a wide range of professional services for the regulatory compliance of medical devices and IVDs. Our comprehensive solutions cater to every class of medical devices, spanning from consultations and coaching to regulatory compliance and worldwide product registration support. With a focus on regulatory affairs, worldwide registrations, clinical services, quality management, artificial intelligence and cybersecurity, ISS AG provides end-to-end assistance throughout the lifecycle of medical devices. Backed by over twenty years of experience, we facilitate the efficient and sustainable market entry of innovative medical solutions. Our services for MedTech and IVD companies: – Regulatory Affairs – Quality Management – International Registrations in more than 110 countries – Clinical Services – Medical Writing (Clinical Evaluation & Performance Evaluation) – Consulting in Digital Services: Cybersecurity & AI
- Website
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http://www.iss-ag.ch
Externer Link zu ISS AG, Integrated Scientific Services
- Branche
- Medizintechnik
- Größe
- 51–200 Beschäftigte
- Hauptsitz
- Biel
- Art
- Kapitalgesellschaft (AG, GmbH, UG etc.)
- Gegründet
- 2003
- Spezialgebiete
- Regulatory Affairs, Clinical Services, Qualitätsmanagement, Software Development und Business Development
Orte
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Primär
Robert-Walser-Platz 7
Biel, 2503, CH
Beschäftigte von ISS AG, Integrated Scientific Services
Updates
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🔬 Zweitägiges HSG Intensivseminar «Strategisches Produkt- und Marketingmanagement in der MedTech Branche» – unverzichtbar für alle, die wettbewerbsfähig bleiben wollen! In der schnelllebigen MedTech-Branche reicht es längst nicht mehr aus, nur innovative Technologien zu entwickeln. Der wahre Wettbewerbsvorteil entsteht durch die strategische Ausrichtung Ihrer Produkte auf die Bedürfnisse Ihrer Zielgruppen. Warum sollten Sie teilnehmen? 🟠 Verschaffen Sie sich einen klaren Wettbewerbsvorteil 🟠 Optimieren Sie Ihren Markteintritt 🟠 Verstehen Sie Ihre Zielgruppen besser 👉 Dieses Seminar bietet Ihnen praxisnahe Strategien, um Ihr Produkt dauerhaft erfolgreich zu positionieren. Datum: 10./11. März 2025 Ort: Hotel Walhalla, St. Gallen #MedTech #MedicalDevice #Produktmanagement #Marketingmanagement #HSG
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Wir freuen uns über die Partnerschaft und darauf, unsere Expertise in der regulatorischen Konformität einzubringen.
𝐕𝐚𝐥𝐢𝐝𝐢𝐞𝐫𝐮𝐧𝐠 𝐯𝐨𝐧 𝐏𝐫𝐨𝐝𝐮𝐤𝐭𝐢𝐨𝐧𝐬𝐩𝐫𝐨𝐳𝐞𝐬𝐬𝐞𝐧: 𝐄𝐢𝐧 𝐞𝐧𝐭𝐬𝐜𝐡𝐞𝐢𝐝𝐞𝐧𝐝𝐞𝐫 𝐒𝐜𝐡𝐫𝐢𝐭𝐭 𝐢𝐧 𝐝𝐞𝐫 𝐌𝐞𝐝𝐓𝐞𝐜𝐡-𝐁𝐫𝐚𝐧𝐜𝐡𝐞! Eine vollständige Prozessvalidierung (IQ, OQ, PQ) garantiert Qualität, Sicherheit und regulatorische Konformität nach ISO 13485, MDR und FDA. Frühzeitige Planung spart Zeit, reduziert Kosten und vermeidet Verzögerungen. Ihre Vorteile: ✅ Effizienter Produktionsstart ✅ Weniger Ausschuss und Nacharbeiten ✅ Einhaltung aller Vorschriften Wir arbeiten mit erfahrenen Compliance-Experten zusammen, um Sie optimal zu unterstützen – von der Dokumentation bis zur Inbetriebnahme Ihrer Maschinen. 📩 Kontaktieren Sie uns für weitere Informationen! [email protected] ISS AG, Integrated Scientific Services
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What do Captain America, Shuri from Black Panther, and the Red Queen Hypothesis have to do with Quality Management Systems (QMS)? 🤔 In our latest blog post, Deborah L. Rossier-Morgenthaler and Bernhard Bichsel dive into the challenges and opportunities of building effective QMS frameworks that balance compliance, operational efficiency, and patient safety. Drawing on fictional allies and real-world insights; they explore how leadership and collaboration are key to overcoming hurdles, fostering a culture of quality ownership, and driving continuous improvement. #medtech #medicaldevices #teamwork #quality #qualitymanagement #CEO #leadership #patientsafety
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🌟 New on our website: Quality Management and Technical Documentation services. Developing and getting medical devices approved can be a complex journey – we bring clarity and structure to help you succeed. Quality Management ✅ Development of ISO 13485-compliant QMS ✅ Audit readiness for global markets (EU, FDA, MDSAP) ✅ GAP analyses & tailored process optimization Technical Documentation ✅ Creation of risk management files, device descriptions & validation reports ✅ Full alignment with EU MDR/IVDR, FDA & international standards ✅ Ensuring successful submissions & accelerated approvals With over 20 years of experience, our team ensures clarity, reduces risks, and empowers you to bring your medical devices to market efficiently. 👉 Visit our webpage and learn how we can support you. #MedTech #QualityManagement #TechnicalDocumentation #ISO13485 #MDR #FDA https://lnkd.in/ewn_gB3H
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⭐ New blog on ISS integrated approach: https://lnkd.in/eDTcdc7k Curious about what happens when a CFO and a risk manager come together – where their fields intersect and spark opportunities to learn from each other? This blog series explores how open communication and a culture of learning not only bridge disciplines but also play a crucial role in driving business success. For an unexpected perspective, find out which fictional character they’d recruit to tackle the unique challenges of compliance, safety, and control. Intrigued? 👉 Read our latest blog to learn more! #medtech #teamwork #medicaldevices #riskmanagement #CFO #finance
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⭐ New blog on ISS integrated approach: https://lnkd.in/g37Bv_nh Curious about what happens when a Regulatory Compliance Expert and an AI Specialist talk shop – where their fields intersect and demand collaboration, how they respond to buzzwords like "efficiency," "security," and "interpretation"? And as a bonus, find out which fictional character they’d add to their team to tackle the unique challenges these fields bring? 👉 Then read on in our blog. #medtech #teamwork #medicaldevices #compliance #regulatoryaffairs #artificialintelligence #AI #KI
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⭐ New blog on ISS Integrated Approach: https://lnkd.in/eyds2BuZ Curious about what happens when a regulatory affairs manager and a project manager talk shop – where their fields intersect and demand collaboration, how they respond to buzzwords like "team," "workload," and "question"? And as a bonus, find out which fictional character they’d add to their team to tackle the unique challenges these fields bring? 👉 Then, read on in our blog. #medtech #teamwork #medicaldevices #projectmanagement #regulatoryaffairs
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🔬 Zweitägiges HSG Intensivseminar «Strategisches Produkt- und Marketingmanagement in der MedTech Branche» – unverzichtbar für alle, die wettbewerbsfähig bleiben wollen! In der schnelllebigen MedTech-Branche reicht es längst nicht mehr aus, nur innovative Technologien zu entwickeln. Der wahre Wettbewerbsvorteil entsteht durch die strategische Ausrichtung Ihrer Produkte auf die Bedürfnisse Ihrer Zielgruppen. Warum sollten Sie teilnehmen? 🟠 Verschaffen Sie sich einen klaren Wettbewerbsvorteil 🟠 Optimieren Sie Ihren Markteintritt 🟠 Verstehen Sie Ihre Zielgruppen besser 👉 Dieses Seminar bietet Ihnen praxisnahe Strategien, um Ihr Medizinprodukt dauerhaft erfolgreich zu positionieren. Datum: 10./11. März 2025 Ort: Hotel Walhalla, St. Gallen #MedTech #MedicalDevice #Produktmanagement #Marketingmanagement #HSG
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👉 New blog on ISS Integrated Approach: https://lnkd.in/eVSgK6WU Curious about what happens when a software engineer and an IVD regulatory affairs manager talk shop — where their fields intersect and demand collaboration, how they respond to buzzwords like "budget," "review," and "planning"? And as a bonus, find out which fictional character they’d add to their team to tackle the unique challenges these fields bring? Then read on in our blog. #medtech #teamwork #compliance #medicaldevices #regulatoryaffairs #software #engineer