Innovation with the Patient in Mind
TRACEABILITY, RISK MANAGEMENT AND RESPONSIVE SUPPLY CHAIN —
Advanced Manufacturing Technologies for Class I, II & III Medical Devices, Biotechnology and Pharmaceutical OEMs
With the global mandate to make healthcare more accessible, affordable and wirelessly connected, medical and life sciences OEMs look to their strategic outsourcing partners more than ever to co-create revolutionary advancements in technology that lower costs and improve outcomes — all without compromising quality and traceability.
As the Internet of Things (IoT) continues to drive astounding breakthroughs in healthcare, patients are becoming more mobile, aware and self-sufficient in their care, while professionals enjoy easier access to data.
Creation delivers proactive design and manufacturing innovation across these healthcare fronts, and more, all while meeting stringent regulatory requirements for ensuring product accuracy and patient safety.
Get the Right Strategic Partner for your OEMs
“Creation’s level of expertise in manufacturing and quality systems is first rate.
Medical Device OEM Specializing in Dental Diagnostics
Look to creation for the solutions you need
Why Partner with Creation for Life Sciences?
NPI & Supply Chain Agility for Highly Complex Products
Fast-track design and functionality validation and get new programs to market quickly with Creation’s expertise in program management and quality and regulatory approvals, and proven methodologies for product transfer and new product introduction (NPI).
Optimize Complex Supply Chain
Creation’s strategic sourcing, commodity management, product cost engineering and international procurement office teams have decades of expertise building and managing responsive, global supply chains proven to produce product on budget and on schedule.
Enjoy Greater Information Access & Visibility
Creation Technologies’ Vision Customer Portal delivers real-time access to order confirmations, tracking info, WIP reporting and excess materials. Learn what it’s like to never again have to ask for an open order report!
- Increased speed-to-market and time-to-volume
- Lean product design, a proven product transfer process and a responsive supply chain
- Master your increasingly complex supply chain by leaving the management to us.
Traceability and Counterfeit & IP Protection
Protect & Sharpen Your Competitive Edge
Strong relationships with Creation’s supply base partners, rigorous materials handling processes and our Vision manufacturing execution system (MES) ensure product traceability down to the component level, counterfeit prevention, and enable asset tracking and serialization.
Trust Our Secure and Reliable Production Environments
Creation protects your IP through secure business systems and information technology that is segregated within the production environment through a cellular manufacturing model.
Rely on Expert Teams Dedicated to Your Products
Creation’s Customer-Focused Team structure also provides you with a dedicated team experienced with medical devices that understands your industry challenges and vernacular.
- Confidence that your information is traceable and secure
- Protection of your brand investment
- Rigorous supply chain controls and secure operations
- Controlled access to your products and information
- Improved communication and collaboration
Quality, Regulatory Compliance & Leadership
Collaborate with Expert Business Units
Creation’s ISO 13485:2016-certified and FDA-registered business units provide design and manufacturing expertise in Class I, II and III Medical Devices, including Pre-Market Approvals and 21 CFR Part 11-validated business systems.
- Outsourcing solutions that mitigate your risk and ensure you meet changing FDA and RoHS requirements
- Leading product quality, regulatory guidance and compliance, and FDA-validated systems
ISO 13485:2016 Certification for Design Controls, Manufacturing, Documentation, & Quality Management System Standards
Standards ISO 9001:2015, ISO 14001:2015 Certifications
FDA-Registered Facilities and Familiarity with End-Customer FDA Audits
Manufacturing Execution System Validated to 21 CFR Part 11
Class I, II and III Expertise and Regulatory Controls
PFMEAs, Verification and Validation Expertise
IPC RoHS Compliance and Environmental Compliance Services
IP Protection through Business Systems Validated for International Traffic in Arms (ITAR) Registration with US Department of State and Canadian Controlled Goods Directorate (CGD)
UL, CSA, TUV, CE, FM, MET, ETL, IEC, IECEx, JPAL