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 Strategy & Submissions Clarity in Complex Regulatory Pathways
We develop and execute regulatory strategies that anticipate FDA expectations and reduce risk across the submission process.
Capabilities:
- 510(k), PMA, and De Novo strategy and execution
- Pre-Submissions and FDA interaction management
- Regulatory pathway and classification assessments
- Deficiency response strategy and remediation
- Change assessments and lifecycle management
What makes us different:
We don’t just prepare submissions, we define the right strategy upfront, avoiding delays, rework, and unnecessary FDA scrutiny.
Clinical Strategy & Study Execution Clinical Programs Designed for Regulatory Success
We ensure clinical evidence is not just generated, but aligned with regulatory expectations and submission goals.
Capabilities:
- Clinical development strategy (IDE, PMA, post-market)
- Protocol design and endpoint selection
- CRO oversight and study management
- Retrospective and prospective study support
- Clinical evaluation and regulatory alignment
Our approach:
Clinical is not a standalone function. We integrate it tightly with regulatory and non-clinical strategy to ensure cohesive, defensible submissions.
Quality & Compliance Quality Systems That Enable, Not Delay
We design and optimize quality systems that support product development while maintaining full regulatory compliance.
Capabilities:
- 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
What you get:
A practical, scalable quality system that supports speed without compromising compliance.
Engineering & Product Development Support Technical Execution Aligned with Regulatory Strategy
Through our engineering partners, we support product development activities that directly impact regulatory success
Capabilities:
- Design and development support
- Verification & validation strategy and execution
- Test method development and documentation
- Usability and human factors integration
- Design history file (DHF) support
Why it matters:
Engineering decisions drive regulatory outcomes as we ensure technical work is structured, documented, and defensible from the start.
Biostatistics Data That Stands Up to FDA Scrutiny
In partnership with biomedical statistical experts, we provide rigorous statistical support across clinical and non-clinical programs.
Capabilities:
- 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
Our edge:
We translate complex data into clear, regulatory-ready evidence that strengthens your submission.
How We Work
A True Extension of Your Team
We integrate across functions including regulatory, clinical, quality, engineering, and biostatistics to eliminate silos and drive efficient execution.
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 FDA Success
- Strategy-first approach to reduce delays and rework.
- 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.