Engineering & Quality Solutions

At Engineering & Quality Solutions, Inc., we are a consulting firm dedicated to providing expert and timely support to our clients in the medical device industry. Our team has extensive experience in the orthopedics industry and offers a wide range of services to help clients succeed in their projects. From surgeon entrepreneurs to multi-million dollar companies, we have worked with clients of all sizes and types.

Our Services

At Engineering & Quality Solutions, Inc., we provide a comprehensive range of services to support our clients' medical device projects. Our services include:

FEA & Engineering Analysis

Our team of experts is well-versed in Finite Element Analysis (FEA) and motion simulation of orthopedic and spinal devices. We can help complete your project portfolio or resolve your design concerns. Our submission-ready FEA reports are professional and comply with FDA guidance for computational modeling.

Product Development

We are your partner in full-service product development, providing support from great idea to successful launch. Our team is committed to timely and consistent tracking and communication, ensuring that your project stays on track and adapts to any challenges that may arise.

Quality Management Systems

Our team is well-versed in quality management systems, including ISO 13485 and ISO 9001, and can help our clients implement and maintain these systems to ensure compliance with regulatory requirements.

Consulting Services

We provide expert consulting services in medical device, orthopedic & spinal devices, product development, design, 3D CAD, engineering, finite element analysis, FEA, quality management system, QMS, ISO 13485, ISO 9001, FDA compliance, FDA 21 CFR 820, design history files, and remediation. Whether you're a start-up or a multi-million dollar company, we're here to support your medical device projects.

Highlights of Experience

Our experience includes:

• Orthopedic Trauma Implants
• Locking & Non-locking Plates
• IM Nails & Lag Screws
• Cortex & Cancellous Screws
• Cannulated Screws
• Locking Screws
• Orthopedic Instruments
• Hand Tools
• Drill Bits & Drill Guides
• Wires
• Spinal Surgery Instruments
• Spinal Devices
• Pedicle Screws
• Rods
• Cervical & Lumbar Plates
• Interbody Fusion Devices (IBFD)
• PLIF, ALIF, TLIF, DLIF
• Expandable Cages