MEDICAL EXPERTISE

OPTIMAL PRODUCTIVITY FOR HEALTHY • ISO 13485 and ISO 9001 standards PROFITABILITY • FDA and CFR requirements Medical device manufacturers operate in one of • Up-front risk assessment the world’s most competitive and highly regulated • Electronic signature and document control capabilities Complete audit trail of manufacturing processes industries where success can hinge on time-to-market • • Comprehensive Corrective Action/ and traceability. That’s why Class 1, 2, and 3 device • Preventative Action (CAPA) functionality manufacturers turn to DELMIAworks for advanced • Non-conforming product review and tracking capabilities that help sustain their competitive advantage. COMPLETE COMMUNICATION The single database structure of DELMIAworks increases MANAGE COMPLIANCE AND QUALITY communication across all your departments. Eliminating DELMIAworks understands that medical manufacturing the need for duplicate data entry translates to features requires higher standards. DELMIAworks’ medical such as customer service being notified about quality quality suite provides the tools and capabilities necessary issues with parts before an order is entered. to cost-effectively manage compliance with quality issues while facilitating internal communication and collaboration. These industry-specific modules address: MEETING MEDICAL DEVICE MANUFACTURERS’ NEEDS DELMIAworks offers a powerful solution tailored to comprehensively meet the unique challenges of the medical manufacturing industry. When FDA compliance, medical device quality and enterprise-wide traceability are critical factors of success, DELMIAworks customers turn to our customized modules (such as our suite of medical quality tools including DHR) to address their ever-evolving and complex needs.

SEAMLESS TRACKING The Device History Record (DHR) module allows medical device manufacturers to cost-effectively:

• Eliminate time-consuming, paper based tracking systems • Streamline product development • Better ensure quality standards compliance • Gain total visibility and control over the manufacturing process POWERFUL TOOLS FOR SUCCESS DELMIAworks offers a comprehensive, enterprise-wide solution that provides a host of critical capabilities needed for success, such as:

• Lot and serial tracking • Warranty and service tracking • Complaint tracking • CAD library management

For more information, please visit www.3ds.com/delmiaworks or call 1.866.367.3772

Our 3DEXPERIENCE® Platform powers our brand applications, serving 11 industries, and provides a rich portfolio of industry solution experiences. Dassault Systèmes, the 3DEXPERIENCE Company, is a catalyst for human progress. We provide business and people with collaborative virtual environments to imagine sustainable innovations. By creating ‘virtual experience twins’ of the real world with our 3DEXPERIENCE platform and applications, our customers push the boundaries of innovation, learning and production.

Dassault Systèmes’ 20,000 employees are bringing value to more than 270,000 customers of all sizes, in all industries, in more than 140 countries. For more information, visit www.3ds.com. © 2019 Dassault Systèmes. All rights reserved. 3DEXPERIENCE®, the Compass icon, the 3DS logo, BIOVIA, GEOVIA, SOLIDWORKS, , ENOVIA, , , MEDIDATA, CENTRIC PLM, 3DEXCITE, , DELMIA, and IFWE are commercial trademarks or trademarks commercial CENTRIC PLM, 3DEXCITE, SIMULIA, DELMIA, and IFWE are NETVIBES, MEDIDATA, SOLIDWORKS, 3DVIA, ENOVIA, EXALEAD, BIOVIA, GEOVIA, the 3DS logo, icon, the Compass All rights reserved. Systèmes. 3DEXPERIENCE®, © 2019 Dassault owners. Use of any Dassault owned by their respective are All other trademarks other countries. and/or States # B 322 306 440), or its subsidiaries in the United Register Commercial (Versailles européenne” “société a French Systèmes, of Dassault trademarks registered approval. written their express is subject to or its subsidiaries trademarks Systèmes

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