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.
Creation Technologies Helps Medical Device, Biotechnology and Pharmaceutical Equipment OEMs Fuel Business Growth with Proactive Design and Manufacturing Solutions that Meet Stringent Regulatory Requirements.
20+ Years in Medical Product Development and Manufacturing that Meets the Stringent Traceability and Quality Requirements of Medical Devices
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
For Medical OEMs, Creation Technologies' Regulatory and Quality Expertise, Supply Chain Agility and Product Traceability Differentiate Us from Other EMS Providers.
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.
Need Help with a Project?
Call toll free 877.734.7456…
Latest Blog Posts
Early in my career, a big part of my job was to coordinate company involvement in various trade shows across North America. I have worked hundreds of industry and association events over the years. As a result, most tradeshows and conferences can look the same to me and I rarely get excited to attend. However,
Today’s electronic devices are incredibly complex. To fully appreciate just how complex, look beyond the advanced physical hardware and micro-circuitry to the sophisticated software layer that controls device functionality. This “command and control” layer comprises an average of one million lines of software code and puts the “Smart” in Smart Products. That much code represents