Traceability, Risk Management and Responsive Supply Chain
for Medical Device, Biotechnology and Pharmaceutical OEMs
There is increasing global pressure on medical and life sciences OEMs from government, insurers and patients to make healthcare more accessible and affordable.
At the same time, emerging communications technology and advancement in bioscience are driving the introduction of revolutionary products.
In this environment with competing priorities, companies producing medical devices are looking ever more to their strategic outsourcing partners to help them provide new innovative, flexible solutions and reduce costs to their customers.
Of course, this innovation and cost reduction can’t come at the expense of the quality and traceability that’s so critical in medical applications.
Turnkey and Partial Product Design & Development
- Specific Regulatory and Quality Expertise for Medical Devices
- In Vitro Diagnostics, Biotechnology Instrumentation, EKG & EEG, Imaging, Diagnostics and Therapeutic Devices
- Optical, Fluidics, Mechanical, RF, Risk Assessment, Verification and Validation, Support for Clinical Trials
- Software from UI to Remote Diagnostics, Firmware, Mobile Apps
Rapid Prototyping and Accelerated Product Transfer
- Risk analysis and regulatory guidance for Class I, II and III medical devices
- ISO 13485 design control, documentation and Quality Management System standards
- Engineering prototyping for PCBAs and complete medical systems
- FDA Pre-Market Approvals
- Rapid Prototyping through Creation Express Services
Lean Manufacturing and Product Traceability
- ISO 13485-certified and FDA-registered business units
- Expertise in Leading-Edge Technology and Complex Systems
- Full Systems Integration and Test, including RF, ESS, HALT, HASS
- Fine-pitch BGAs, New Chipsets, DFM for Small Components
- Electromechanical Assembly Expertise
- Conformal Coating & Potting
- Clean Room Manufacturing
- Full component-level and product-level traceability and HIPPO data management
Direct Fulfillment & Logistics for Complex Systems
Product Lifecycle Management (PLM) and Sustaining Engineering
24/7 Visibility through Creation's Vision Customer Portal
- Access to Critical Supply Chain, Operational and Quality Data through Creation’s Vision Customer Portal
How are connected devices shaping the future of healthcare?
The billion-device, billion-dollar Internet of Things (IoT) holds the potential to dramatically transform healthcare.
Wirelessly connected medical devices increase patient mobility while giving healthcare professionals real-time access to patient data, throughout the hospital, and at the point of care.
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How Does Your Product Development Cycle Stack Up? Did you know that Deere & Company reduced product development time for construction equipment by 60%, and IBM reduced direct costs in system assembly by 50%? And how did Fuji Xerox’s FX-3500 copier immediately capture 60% of the relevant domestic market? All are historical reference points to
Global competition in the medical device industry is fierce and if your company is not constantly innovating and evolving, you are likely being left behind. For medical device companies in the New York region, staying stagnant is not an option. This tight-knit community plans on being assertive in creating medical devices that will improve lives