Innovation, compliance, and safety are essential in today’s rapidly evolving life sciences industry. We have the expertise and advanced laboratory facilities to assist you at every stage of the Total Product Life Cycle (TPLC), from conceptual design and development to manufacturing support and post-market analysis.
Our multidisciplinary team features biomedical engineers and scientists with advanced degrees in biomaterials, mechanical engineering, and biomechanics. With extensive experience in both FDA submissions and international regulations, we can guide you through the intricacies of compliance, from preclinical testing, design validation, and risk management, to post-market surveillance.
Our nationwide network of laboratories is equipped to conduct preclinical testing, numerical simulations, and failure analyses. We also develop custom testing for new products to ensure they meet the highest standards while maintaining your competitive edge.
We offer expert insight into product liability disputes, intellectual property cases, and technology acquisitions. We help minimize potential liabilities by developing robust risk management strategies that prioritize safety and compliance. Our consultants actively participate in the scientific community by serving on expert panels and contributing to international standards and regulatory guidelines.
Jorge A. Ochoa
Principal
ESi Life Sciences Capabilities
- Regulatory Compliance
- Preclinical Testing
- Total Product Life Cycle Management
- Numerical Simulations
- Failure Investigation and Root Cause Analysis
- Risk Management
- Product Liability
- FDA Medical Device Authorization Support (Class I, II, and III)
- International Compliance
- Intellectual Property Disputes
- Biomaterials Science and Engineering
- Medical Devices
- Diagnostic Devices
- Prototyping and Testing
- Human Factors in Medical Devices
- Patent Due Diligence
- Compliance and Safety
- Litigation Support
- Regulatory Support
