LG STRATEGIES LLC (TX)

Federal Capability Statement

LG Strategies, LLC is an engineering, regulatory, and quality consulting firm specializing in medical device regulatory strategy. LG Strategies specializes in guiding organizations using additive manufacturing (3D printing) in the medical device and healthcare industry. The group provides strategic technical and professional services to facilitate scaling up of quality management systems (QMS) including providing guidance and structure for standard operating procedures, work instructions, and risk analysis for organizations using 3D printing in medical device manufacturing; collaborating, writing, and/or reviewing regulatory submissions to governing bodies such as the United States FDA. The group has an understanding of point of care 3D printing principles and guidelines thus far shared by the regulatory bodies including the US FDA. The principal consultant has experience working across multiple sites with multi-billion dollar medical device corporations.