Engineering & Quality Solutions

Expert Guidance for Medical Device Success

Engineering & Quality Solutions, Inc. is your trusted consulting partner for navigating the complex landscape of medical device development and manufacturing. With a wealth of expertise in the orthopedic industry, our team has assisted surgeon entrepreneurs, startups, and established companies in achieving success from ideation to market launch.

Our Approach

We understand that every project is unique, which is why we take a personalized approach to every engagement. Our consultants work closely with clients to identify their specific needs and goals, developing tailored solutions that align perfectly with their aspirations.

1. Product Development & Design

• Design problem solving and optimization
• Design for manufacturability
• Design controls and risk management
• Regulatory compliance support (21 CFR 820)

2. Engineering & Analysis

• Finite Element Analysis (FEA) and motion simulation
• Engineering investigations and analysis
• Risk assessment and mitigation
• Quality management system implementation and training

3. Manufacturing & Validation

• Manufacturing process optimization
• Quality control and testing
• Regulatory submission preparation
• Device testing and validation

4. Consulting & Training

• Market analysis and feasibility studies
• Regulatory compliance guidance
• Training programs for manufacturers and engineers
• Quality system assessments and improvement plans

Our Clients

We have had the privilege of working with:

• Surgeon entrepreneurs with groundbreaking device ideas
• Startup companies disrupting the industry
• Established medical device manufacturers
• Established medical device manufacturers

Our Commitment

At Engineering & Quality Solutions, Inc., we are committed to:

• Expertise: Our team boasts extensive experience and unparalleled knowledge in medical device development.
• Timeliness: We understand the need for swift and efficient solutions, delivering results without compromising quality.
• Confidentiality: Your sensitive data is treated with the utmost confidentiality and security.

Partner with Engineering & Quality Solutions, Inc. and achieve success in the competitive medical device industry!