The client, being a leading pediatric orthopedic company, wanted to interpret and Re-engineer few instrument designs in order to achieve their quality standards on the components. Our involvement included designing of Orthopedic surgical components, detailing and adding part attributes to the components for quick identification using Unigraphics NX CAD software application.
The client is a Warsaw, Indiana, based pediatric orthopedic company, focused globally on the unmet needs of children suffering from orthopedic issues. They have a mission to provide anatomically appropriate, innovative implants and instruments in sterile packed, single-use disposable procedure kits to surgeons and their patients who are still growing.
- Incorporated ISO 9001 for general standard for quality management
- Incorporated ISO 13485 for the quality management system specifically designed for medical device manufacturers
- Provided output Model and drawings in NX format (company template) along with drawing PDF’s.
- Maintaining Design History Files (DHF’s) per company procedures. Ensure that DHF’s are accurate, complete and well organized.
- Design the models completely parametric and incorporate the Standard designing practices.
- Maintain Precisions, Tolerances, GD&T symbols and standards on the drawings.
- Provided Delivery sheet which contained the entire quality check points for executing design projects to all their valuable clients.
- Determining if the product meets the definition of a medical device per Section 201(h) of the Food, Drug & Cosmetic Act.
Benefits to the Client:
With a strong PLM foundation, the client was able to witness the following benefits to its business operations:
- Reduction in safety and legal risks while creating more economical work environments
- Safely produced medical device.
- Led to increased device sales
- Optimal development and support cost with increased productivity and continuous improvements
- Reduce operational costs by highlighting process deficiencies and improving efficiency