Our Services
Integrated Expertise for Complex Medical Device Programs
Coladonato Consulting provides end-to-end support across regulatory, clinical, quality, engineering, and biostatistics. We operate as a unified partner, aligning every function to a single goal: a clear, efficient path to FDA success.
Regulatory
We develop and execute regulatory strategies that anticipate FDA expectations and reduce risk across the submission process.
- 510(k)s
- Change assessments and lifecycle management
- Deficiency response strategy and remediation
- De Novos
- IDEs
- PMAs
- Q-Submissions
- Regulatory pathway and classification assessments
- Test plans / acceptance criteria generation
Clinical
We ensure clinical evidence is not just generated, but aligned with regulatory expectations and submission goals.
- Clinical development strategy
- Protocol design and endpoint selection
- CRO oversight and study management
- Clinical evaluation and regulatory alignment
Biostatistics
Biomedical statistical experts that provide rigorous statistical support across clinical and non-clinical programs.
- Statistical analysis plans (SAPs)
- Study design and sample size justification
- Data analysis for clinical and bench studies
- Support for regulatory submissions and responses
- Interpretation and presentation of complex data
Engineering
We support product development activities that directly impact regulatory success
- Design and development support
- Verification & validation strategy and execution
- Test method development and documentation
- Usability and human factors integration
- Design history file (DHF) support
Quality
We design and optimize quality systems that support product development while maintaining full regulatory compliance.
- QMS development and implementation (21 CFR 820 / ISO 13485)
- Design controls and risk management
- Gap assessments and remediation
- Audit readiness and inspection support
- Supplier and manufacturing quality integration
Direct access to senior expertise
Fast, responsive communication
Flexible support tailored to your program
Focus on outcomes, not just deliverables
A Clear, Efficient Path to Success
- Client centric approach to ensure success.
- Deep expertise in Class II & III, spine, orthopedic, and combination products.
- Integrated support across regulatory, clinical, quality, engineering, and biostatistics.
- Direct access to senior experts with fast, responsive communication.
- Proven execution under tight timelines and high-stakes conditions.