Loukas Medical Inc.

Orthopedic Design and Consulting

Services

Loukas Medical will provide the design of proprietary orthopedic surgical instrument designs for sale or modification to Orthopedic OEM companies.  The team at Loukas Medical has many years of experience with orthopedic implants and instruments.  We have worked with physicians, engineers, the FDA and hundreds of OEM orthopedic companies.  These services include, but are not limited to:

• Spinal Implant Systems.  The founder and president of LMI has personally worked, or been in surgery with, many of the past presidents of NASS.  Having been in the spine industry since the mid 1980s he is very familiar with the needs and requirements of spinal surgery.  Bring your designs to LMI for review and/or a complete redesign.
• Instrument Design  The team at Loukas Medical is known throughout the world for innovative design.  We are able to design your medical devices that will be unique to your application thus giving you an edge on your competition.
• Design Controls  We are also very familiar with the design control requirements of the FDA and ISO13485.  We will provide the data for your design control procedures and history files.
• Consulting  Loukas Medical will consult with you team to lay a solid foundation for your next project.  We are knowledgeable in implant design and use, and will work with your product development team to co-develop your complete implant system.  We understand the necessity that both implants and instruments are ready for delivery at the same time for a successful product launch.
• Prototyping  We have the resources available to provide quick prototyping.
• Manufacturing  Though Loukas Medical does not manufacture finished production runs we have the experience of over 30 years with modern manufacturing methods.  Loukas can assist your manufacturing facilities in the development of usable Device Master Records.