Matrix Medical Devices
Consulting firm focused on medical device commercialization, providing regulatory strategy and submissions, quality management system implementation and remediation, program and product development management, and clinical study support for US and international markets.
Industries
Nr. of Employees
small (1-50)
Matrix Medical Devices
5900 Landerbrook Dr #350, Mayfield Heights, OH 44124
Products
FDA/Regulatory Services
Provides regulatory strategy and support for FDA 510(k) and PMA submissions, including gap analysis, procedures, and design control implementation.
Quality Systems Services
Establishes and maintains quality system infrastructure to ensure compliance with FDA and ISO standards, including inspection preparation and risk management.
Program Management Services
Offers hands-on management of product development priorities, resource planning, budgeting, and post-market surveillance activities.
Clinical Studies Support
Supports clinical study design, FDA IDE preparation, site qualification, and adverse event reporting to establish product value.
Additional Growth Resources
Provides due diligence, organizational assessment, design transfer guidance, and access to a quality supplier network.
FDA/Regulatory Services
Provides regulatory strategy and support for FDA 510(k) and PMA submissions, including gap analysis, procedures, and design control implementation.
Quality Systems Services
Establishes and maintains quality system infrastructure to ensure compliance with FDA and ISO standards, including inspection preparation and risk management.
Program Management Services
Offers hands-on management of product development priorities, resource planning, budgeting, and post-market surveillance activities.
Clinical Studies Support
Supports clinical study design, FDA IDE preparation, site qualification, and adverse event reporting to establish product value.
Additional Growth Resources
Provides due diligence, organizational assessment, design transfer guidance, and access to a quality supplier network.
Services
Regulatory strategy and scalable support for pre-market pathways, predicate identification, gap analysis, procedures, training and design controls including DHF creation.
Establish and remediate quality systems, inspection preparation, risk management, supplier qualification, and responses to regulatory inspection findings.
Hands-on program management for product development including prioritization, resource planning, budgeting, grant support and critical-path management.
Clinical study design, IDE and IRB package preparation, clinical site qualification and start-up, and adverse event reporting guidance.
Regulatory strategy and scalable support for pre-market pathways, predicate identification, gap analysis, procedures, training and design controls including DHF creation.
Establish and remediate quality systems, inspection preparation, risk management, supplier qualification, and responses to regulatory inspection findings.
Hands-on program management for product development including prioritization, resource planning, budgeting, grant support and critical-path management.
Clinical study design, IDE and IRB package preparation, clinical site qualification and start-up, and adverse event reporting guidance.
Expertise Areas
- Regulatory compliance and submissions for medical devices
- Quality management system implementation (ISO 13485, FDA QSR)
- Clinical study design and clinical regulatory support
- Medical device product development and engineering
Key Technologies
- Regulatory submissions (510(k), PMA, IDE, CE marking)
- ISO 13485 and FDA QSR 21 CFR 820 compliance
- Design controls and Design History Files
- Verification and validation methodologies (bench, cadaver, in-vivo, usability)
News & Updates
Announcement of an addition to the leadership team in response to business growth.
Company expands services to include engineering and product development in response to client demand.
Company participation moderating a panel on 3D printing in medical devices.
Announcement of an addition to the leadership team in response to business growth.
Company expands services to include engineering and product development in response to client demand.
Company participation moderating a panel on 3D printing in medical devices.