Accelerate your product commercialization.
Matrix Medical Devices offers a robust regulatory and quality foundation, enabling an efficient development process for current and future products.
In addition, we offer other resources for growth including due diligence, organizational assessment, design transfer guidance and a quality supplier network.
Our team will outline a complete 510(k) or PMA regulatory strategy based on your business goal. Our team offers scalable support, including regulatory strategy, gap analysis, procedures, training, FDA design controls and Design History File creation.
- FDA and CE Device Classification
- Regulatory Predicate Identification and Benchmarking
- Audit Preparation
- US and OUS Regulatory Strategy
- Comprehensive Development Team Regulatory Support
- Complete Design Control Implementation
We’ll establish a sound quality foundation from the onset and help you maneuver through the process with assurance.
- Inspection Preparation
- Quality System Establishment
- Quality System Compliance
- Risk Management
- FDA 483 Inspection Responses and Remediation
- Supplier Qualification
With “hands-on” technical experience in product development and production, we also provide expertise on product development priorities and critical-path activities. Additionally, for post-market surveillance activities we “sit on the same side of the table" – making sure Quality improvement and response initiatives are not only effective but are optimized for speed and relevance.
- Product Development Planning
- Resource Needs and Recommendations
- Organizational Recommendations
- Hands-on Program Management
- Program Cost Estimates and Budgeting
- Grant Applications and Review
From preparing FDA IDEs to clinical study kick-off, we provide the expertise and input to achieve the clinical study outcomes that will establish your product’s value proposition.
- Clinical Study Design
- Investor Brochures
- IRB and IDE Packages
- Clinical Site Qualification and Start-Up
- Adverse Event Guidelines and Reporting