Stratasys Expands Market Opportunities for Medical Device Manufacturers to Leverage 3D Printing to Enhance Innovation and Improve Patient Outcomes
Stratasys (NASDAQ: SSYS) announced that its Stratasys Direct manufacturing facility in Tuscon, Arizona has achieved ISO 13485 certification, a globally recognized standard for quality management systems in medical device manufacturing. The company plans to extend this certification to its facilities in Texas and Minnesota.
The certification formally recognizes Stratasys Direct's safety, precision, and reliability in producing 3D-printed components, addressing critical regulatory requirements and enabling medical device manufacturers to scale production while accelerating innovation. The company specializes in creating complex geometries and patient-specific components that traditional manufacturing methods cannot achieve.
This certification positions 3D printing as an essential tool for the medical device industry, offering benefits such as reduced development times, highly customized components, and faster innovation compared to traditional manufacturing methods.
Stratasys (NASDAQ: SSYS) ha annunciato che il suo stabilimento di produzione Stratasys Direct a Tucson, Arizona, ha ottenuto la certificazione ISO 13485, uno standard riconosciuto a livello globale per i sistemi di gestione della qualità nella produzione di dispositivi medici. L'azienda prevede di estendere questa certificazione ai suoi impianti in Texas e Minnesota.
La certificazione riconosce formalmente la sicurezza, la precisione e l'affidabilità di Stratasys Direct nella produzione di componenti stampati in 3D, affrontando i requisiti normativi critici e consentendo ai produttori di dispositivi medici di scalare la produzione velocizzando l'innovazione. L'azienda si specializza nella creazione di geometrie complesse e componenti specifici per i pazienti che i metodi di produzione tradizionali non possono raggiungere.
Questa certificazione posiziona la stampa 3D come uno strumento essenziale per l'industria dei dispositivi medici, offrendo vantaggi come tempi di sviluppo ridotti, componenti altamente personalizzati e un'innovazione più rapida rispetto ai metodi di produzione tradizionali.
Stratasys (NASDAQ: SSYS) anunció que su instalación de fabricación Stratasys Direct en Tucson, Arizona, ha logrado la certificación ISO 13485, un estándar reconocido mundialmente para sistemas de gestión de calidad en la fabricación de dispositivos médicos. La empresa planea extender esta certificación a sus instalaciones en Texas y Minnesota.
La certificación reconoce formalmente la seguridad, precisión y fiabilidad de Stratasys Direct en la producción de componentes impresos en 3D, abordando requisitos regulatorios críticos y permitiendo a los fabricantes de dispositivos médicos escalar su producción mientras aceleran la innovación. La empresa se especializa en crear geometrías complejas y componentes específicos para pacientes que los métodos de fabricación tradicionales no pueden lograr.
Esta certificación posiciona la impresión 3D como una herramienta esencial para la industria de dispositivos médicos, ofreciendo beneficios como tiempos de desarrollo reducidos, componentes altamente personalizados y una innovación más rápida en comparación con los métodos de fabricación tradicionales.
스트라타시스 (NASDAQ: SSYS)는 애리ゾ나주 투손에 위치한 스트라타시스 다이렉트 제조 시설이 의료기기 제조를 위한 품질 관리 시스템에 대한 전 세계적으로 인정받는 표준인 ISO 13485 인증을 획득했다고 발표했습니다. 회사는 이 인증을 텍사스 및 미네소타 시설로 확장할 계획입니다.
이 인증은 스트라타시스 다이렉트가 3D 프린팅 부품을 생산하는 데 있어 안전성, 정밀성 및 신뢰성을 공식적으로 인정하며, 중요한 규제 요건을 충족시키고 의료기기 제조업체가 생산을 확장하면서 혁신을 가속화할 수 있도록 합니다. 회사는 전통적인 제조 방법으로는 달성할 수 없는 복잡한 기하학적 형태와 환자 맞춤형 구성 요소를 만드는 데 특화되어 있습니다.
이 인증은 3D 프린팅을 의료기기 산업의 필수 도구로 자리잡게 하며, 전통적인 제조 방법에 비해 짧은 개발 시간, 높은 맞춤형 구성 요소, 그리고 더 빠른 혁신 같은 이점을 제공합니다.
Stratasys (NASDAQ: SSYS) a annoncé que son installation de fabrication Stratasys Direct à Tucson, en Arizona, a obtenu la certification ISO 13485, une norme reconnue mondialement pour les systèmes de gestion de la qualité dans la fabrication de dispositifs médicaux. L'entreprise prévoit d'étendre cette certification à ses installations au Texas et au Minnesota.
La certification reconnaît formellement la sécurité, la précision et la fiabilité de Stratasys Direct dans la production de composants imprimés en 3D, répondant ainsi aux exigences réglementaires critiques et permettant aux fabricants de dispositifs médicaux d'augmenter leur production tout en accélérant l'innovation. L'entreprise est spécialisée dans la création de géométries complexes et de composants spécifiques aux patients que les méthodes de fabrication traditionnelles ne peuvent pas réaliser.
Cette certification positionne l'impression 3D comme un outil essentiel pour l'industrie des dispositifs médicaux, offrant des avantages tels que des délais de développement réduits, des composants hautement personnalisés et une innovation plus rapide par rapport aux méthodes de fabrication traditionnelles.
Stratasys (NASDAQ: SSYS) hat bekannt gegeben, dass ihre Stratasys Direct Fertigungsstätte in Tucson, Arizona, die ISO 13485-Zertifizierung erhalten hat, einen weltweit anerkannten Standard für Qualitätsmanagementsysteme in der Herstellung von Medizinprodukten. Das Unternehmen plant, diese Zertifizierung auf seine Einrichtungen in Texas und Minnesota auszuweiten.
Die Zertifizierung erkennt formell die Sicherheit, Präzision und Zuverlässigkeit von Stratasys Direct bei der Produktion von 3D-gedruckten Komponenten an, erfüllt kritische regulatorische Anforderungen und ermöglicht es Herstellern von Medizinprodukten, die Produktion zu skalieren und gleichzeitig die Innovation zu beschleunigen. Das Unternehmen ist auf die Erstellung komplexer Geometrien und patientenspezifischer Komponenten spezialisiert, die mit traditionellen Fertigungsmethoden nicht erreicht werden können.
Diese Zertifizierung positioniert 3D-Druck als ein unverzichtbares Werkzeug für die Medizinprodukteindustrie und bietet Vorteile wie verkürzte Entwicklungszeiten, hochgradig angepasste Komponenten und schnellere Innovationen im Vergleich zu traditionellen Fertigungsmethoden.
- Achieved ISO 13485 certification for medical device manufacturing
- Plans to extend certification to additional facilities in Texas and Minnesota
- Enables scaling of medical device production with regulatory compliance
- Strengthens position in medical manufacturing market
- None.
Insights
The ISO 13485 certification secured by Stratasys Direct's Tucson facility marks a pivotal strategic expansion into the
The planned certification expansion to facilities in Texas and Minnesota reveals a comprehensive strategy to create a nationwide network of medical-grade 3D printing centers. This positions Stratasys to capture a larger share of the medical device market, particularly in high-margin, patient-specific components where traditional manufacturing methods fall short.
Key competitive advantages include:
- Reduced regulatory compliance costs for medical device manufacturers
- Accelerated time-to-market for new medical devices
- Capability to produce complex geometries impossible with traditional manufacturing
- Scalable production of patient-specific components
The business impact extends beyond immediate revenue potential. Medical device manufacturers typically maintain long-term supplier relationships due to regulatory requirements, suggesting this certification could generate stable, recurring revenue streams. The timing aligns with increasing adoption of 3D printing in medical manufacturing, projected to grow at
This certification positions Stratasys at the intersection of two transformative healthcare trends: precision medicine and advanced manufacturing. The ability to produce patient-specific components could significantly impact treatment outcomes in complex procedures, particularly in orthopedics, cardiovascular devices and surgical instruments.
The business implications are substantial:
- Reduced manufacturing costs through elimination of tooling and minimal material waste
- Faster iteration cycles for medical device development
- Enhanced ability to produce small-batch, customized medical devices
- Improved inventory management through on-demand production
The certification's timing is particularly strategic as healthcare providers increasingly seek cost-effective solutions for personalized medical devices. This could accelerate adoption in key growth areas such as dental devices, surgical guides and prosthetics, where customization significantly impacts patient outcomes.
Stratasys Direct’s New ISO 13485 Certification Meets Stringent Regulatory Requirements Essential for Medical Device Manufacturers
By achieving ISO 13485 certification, Stratasys Direct is formally recognized for its safety, precision, and reliability of its 3D-printed components. This certification addresses critical regulatory requirements, removing barriers to adoption and enabling medical device manufacturers to scale production reliably while accelerating innovation, reducing costs, and improving patient outcomes.
Stratasys Direct 3D prints multiple components for the medical industry making complex geometries and patient-specific components that traditional methods cannot achieve.
"ISO 13485 certification is a game-changer for medical manufacturing," said Gurvinder Kahlon, General Manager and Vice President, Stratasys Direct. "This achievement reflects our commitment to delivering solutions that not only meet rigorous regulatory standards but also empower the medical industry to innovate faster and deliver better patient care."
Stratasys Direct has been a trusted partner to the medical field for years, delivering custom 3D-printed models and components. The ISO 13485 certification builds on that legacy, positioning 3D printing as an essential tool for the medical device industry. By adopting 3D printing, medical manufacturers can reduce development times, create highly customized components, and innovate faster than with traditional manufacturing methods. Stratasys Direct’s ISO 13485 certification provides a clear pathway to regulatory compliance, ensuring consistent quality and expanding market access for these advanced manufacturing solutions.
Stratasys Direct will showcase its capabilities and commitment to the medical industry at MD&M West, taking place February 4-6, 2025, in
About Stratasys
Stratasys is leading the global shift to additive manufacturing with innovative 3D printing solutions for industries such as aerospace, automotive, consumer products, and healthcare. Through smart and connected 3D printers, polymer materials, a software ecosystem, and parts on demand, Stratasys solutions deliver competitive advantages at every stage in the product value chain. The world’s leading organizations turn to Stratasys to transform product design, bring agility to manufacturing and supply chains, and improve patient care.
To learn more about Stratasys, visit www.stratasys.com, the Stratasys blog, X/Twitter, LinkedIn, or Facebook. To learn more about Stratasys Direct’s 3D printing services, visit https://www.stratasys.com/en/stratasysdirect/. Stratasys reserves the right to utilize any of the foregoing social media platforms, including Stratasys’ websites, to share material, non-public information pursuant to the SEC’s Regulation FD. To the extent necessary and mandated by applicable law, Stratasys will also include such information in its public disclosure filings.
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Media and Investor Contacts:
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Source: Stratasys Ltd.
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