XCIX Design, LLC

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.