High stakes for Medical Product Development
Product development in the medical technology arena demands continuous attention to a rapidly evolving landscape.
Technology and end markets change very quickly, and new competitors emerge overnight.
End markets and end customers are ever more engaged — and more critical — as the medical industry trends toward connectivity, personalization and self-service.
Clinical and regulatory requirements are constantly shifting thanks to legal and legislative developments.
Get Value at Critical Junctures
“Creation Design Services focuses on developing long-term relationships with their clients, providing value at critical junctures and pointing out where efficiencies and savings can be found.”
Medical Device OEM Specializing in Neurotherapy and Neurodiagnostics
Creation Technologies Has the Medical Design and Development Expertise to Help You Navigate Shifting Landscapes and Capitalize on Opportunities ahead of Your Competition.
For 25 years, Creation Technologies has helped OEMs in healthcare and the life sciences introduce new products, while sustaining and improving existing ones.
Whether you need short-term, focused design support or turnkey product development, Creation Design Services will provide you with high-quality, innovative medical devices that are both safe and certified.
Creation Design Services has experience with Class I, II, & III devices from complex FDA-approved products to software apps for wireless devices.
Medical Product Development Expertise
- In Vitro Diagnostics (Benchtop and POC)
- Biotechnology Instrumentation
- Ablation Technologies
- Energy-Delivering Diagnostic and Therapeutic Devices
- EKG & EEG Applications
- Pulse Oximetry
- Dental Equipment
- Topographic Imaging
Medical Regulatory Development Expertise
- Risk Analysis & Regulatory Guidance for Class I, II and III Medical Devices
- ISO 13485 Design Control, Documentation & Quality Management System Standards
- FDA Current Good Manufacturing Practices (cGMPs) for Quality System Regulation 21CFR Part 820, Support for Entire FDA Approval Process
- ISO 14971 Risk Management Safety Regulation for Medical Products
- UL 60601-1 Compliance & Patient Contact Devices
- Complete Medical Product Systems Design & Development or Design Support
- Third Party Design Review, including Design History File (DHF) Analysis & Remediation
- Design Verification & Support for Clinical Trials
- Design & Actuation of Manufacturing Fixtures including IQ/OQ and PQ
A Note on RFID and Medical Devices
Introduced in 2007, the FDA Administration Amendments Act requires that all medical devices carry a Unique Device Identifier, or UDI.
Passive and active RFID tags are an excellent choice for many UDI solutions. Beyond the regulated requirements like storing a serial number, a well-designed tag can store manufacturing information, service history or a variety of other important and useful data.
Creation Technologies has vast experience providing design and manufacturing-related RFID solutions.
On the design and development side, this experience includes active tags, passive tags and readers, from those used for tracking of Department of Defense “high energy” devices, to tags used in amusement parks for tracking the movement of children.
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For those of us who live in the Bay Area, there are three constants in life: we love our weather, we love our sports teams, and most of all, we love to win. Based in San Jose, where I am the Western VP of Business Development for Creation Technologies, I am no different. That is
As Director of Regulatory & Quality for Creation Design Services, I continuously ask the question, “Is there value-add with the new UDI System?” The regulations to make medical devices safer and with the highest possible quality are constantly evolving. A good example of this has been the implementation of the Medical Device UDI System. The