Medical Device Consulting Services
Areas of Expertise
-Spinal Implants
-New/Novel Ideas
-Optimize Fit and Function
-Resolve Manufacturing and Assembly Issues
-DFMEA/PFMEA
-Reduce Cost
-Process Validations
-Surgical Instruments
Product Development Services:
Whether you are developing a new product or modifying and existing one you can leverage our expertise to move your product forward.
Small organizations are faced with difficult decision when it comes to the management of time and resources. Complex solutions that better meet the needs of the user are often ignorded so valuable resources are not drained and critical timelines are met. XCIX Design specializes in complex solutions; let us focus on the most difficult instruments or implants so your project launch is not delayed.
XCIX Design can quickly develop custom instruments for surgeons so your internal resource can focus on new product development.
Quality System Installation, Maintenance, and Training Services:
We have extensive expertise in Quality System design and implementation, we can help new organizations implement a Quality System that meets their needs, develop single custom procedures or maintain/update your current system.
We can quickly develop custom procedures that meet your organizational needs. We can typically provide a rough draft Quality Procedure in as little as a few days. Don’t let quality system issues tie up your internal resources.
XCIX Design can provide an “independent” internal auditor.
Regulatory, 510(k) Submissions and Review Services:
Organization can benefit from our knowledge of FDA regulatory requirement by allowing us to assist in the authoring and compiling of 510(k) submission. We can help identify the best regulatory strategy’s early only on in the development process to help insure a seamless approval.
Regulatory strategy includes; required testing, test acceptance criteria, Indications for Use Statements, Surgical Technique, and benchmark analysis.
Company Details
- Employees
- 2
- Founded
- -
- Address
- Par, Utah 84328, Us
- Industry
- Medical Device
- Website
- http://xcixdesign.com
- HQ
- Par, UTAH
Xcix Design, Llc Questions
Xcix Design, Llc's website is http://xcixdesign.com
Xcix Design, Llc's LinkedIn profile is https://www.linkedin.com/company/xcix-design
Xcix Design, Llc has
2 employees.
View email and phone details for 2
employees at Xcix Design, Llc.
Xcix Design, Llc's industry is
Medical Device
Xcix Design, Llc's top competitors are
Happe Spine,
High Creek Fly Fishing,
Bk Meditech Usa,
Pinnacle Spine Group,
Matador Medical Management Llc,
Spinepoint,
Vgi Medical, Llc,
Hammill Medical,
Bay Fusion,
Regeltec, Inc.
Xcix Design, Llc's categories are Medical Device
Xcix Design, Llc's founding year is 2020
