Innovation, efficacy, compliance, and safety are essential in today’s rapidly evolving life sciences industry, and our team of experts is here to investigate failures and solve difficult technical problems. We posess the expertise and laboratory facilities required for every stage of the Total Product Life Cycle (TPLC), from conceptual design to manufacturing support and post-market analysis.
Our nationwide network of laboratories is equipped to conduct preclinical testing, numerical simulations, and failure analyses, and our team of experts includes biomedical engineers and scientists with advanced degrees across multiple disciplines. With extensive experience in both FDA submissions and international regulations, we guide clients through the intricacies of technical risk management, from preclinical laboratory testing, design verification/validation, and compliance, to post-market surveillance.
Our consultants offer expert insight into product liability disputes, intellectual property cases, and technology acquisitions, minimizing potential liabilities by developing robust risk management strategies that prioritize safety and compliance.
Expert Support Throughout the Product Lifecycle
Jorge A. Ochoa
Director, Principal
ESi Life Sciences Capabilities
- Compliance and Safety
- Computation Fluid Dynamics (CFD)
- Computational Modeling and Simulation
- Corrosion Testing (ISO 17025)
- CT (ISO 17025)
- Diagnostic Devices
- Drug Delivery Devices
- FDA Medical Device Authorization Support (Class I, II, and III)
- Finite Element Analysis (FEA)
- Intellectual Property Disputes
- Litigation Support
- Medical Devices, Diagnostic and Drug Delivery Devices
- Patent and Technical Due Diligence
- Pharmaceutical Packaging
- Product Liability
- Prototyping and Testing
- Regulatory Support and Compliance
- Retrieval Analysis (ISO 17025)
- Risk Management
- Root Cause Analysis
- Test Method Development
- Total Product Life Cycle Management
- 3rd Party Design Assessments
