Medical Device Design & Product Development Services

We help you research, design, and develop your medical products.

Our Medical Device Design & Product Development Services

The road to transforming an innovative idea for a medical device into a tangible, marketable product can be challenging. We can help make it real.

From initial concept definition and planning to eventual design verification and validation, you may not know where to start.

But you don’t have to navigate this challenging process alone.

The medical device design and product development consultants at M.L. Reo Consulting has experience and knowledge in the medical device industry. We can help you develop a plan to appropriately research, develop, and design your medical device.

Furthermore, once your product is developed and designed, we can aid you in the manufacturing and operations, clinical affairs and regulatory affairs compliance, and quality management systems for your new medical device.

Design Controls

Expert Design Controls Support:

Compliant with cGMP, ISO13485, and MDR, All phases of Design Controls, Specifications, Risk Management, Design Inputs, Design Outputs, Design Verification & Validation Testing

Computer-Aided Design (CAD)

Expert CAD Support:

SolidWorks, AutoCAD, Solid Models: Components, Assemblies, Drawings, Template Development, Design Tables

Prototyping: Product & Equipment

All levels of Prototyping:

In-house CNC Machining Capability, Rapid Prototyping, Assembly, Fabrication - implants, catheters, surgical instruments, PCBA, programming, electromechanical systems, and chassis ...We use these same skills to build fixtures and equipment for DV&V or produciton.

Product Requirements

Get the Requirements Right:

Experience-based approach to requirements development, deep understanding of regulatory implications, traceability matrix development, justifications and references - User Needs and Intended Uses, Qualitative Design Inputs, Quantitative Design Inputs...forwarding looking to necessary Design Outputs

Hazard Analysis

Foundation of Risk Analysis:

Setup compliant, traceable, and meaningful Hazard Analysis - Patient, User, and Product

Concept Definition & Planning

Clearly Defined Plans:

Concept phase planning is essential for creating guidelines for downstream development - Product Definition signed by executive management, Sales & Marketing Plan, Regulatory Plan, Product Development Plan

User FMEA

Bottom-up IFU Analysis:

Ensure all sections of IFU are analyzed, ultimately mitigating user and patient risk

Design FMEA

Bottom-up Component Analysis:

Cover all components and key areas of interest to regulators. Find and reduce component risks early in the design process.

Design Verification & Validation

DV&V Planning:

Design Verification & Validation (DV&V) testing begins with a product specification trace matrix lining up all user needs & intended uses (typically qualitative design inputs) with quantitative design inputs, standards, testing, and design outputs - results are a compliant set of Test Method Validations (TMV), protocols, and test reports demonstrating with objective evidence the product can meet its requirements.

Your Medical Device Engineering & Development Experts

50+ Years of Industry Experience

M.L. Reo Consulting is a unique medical device design and development firm, with a combined experience of over 50 years.

We’ve worked with companies and projects of all sizes, from start-ups to established manufacturers, to design and develop medical devices as well as custom fixtures and equipment.

It is this breadth of experience that distinguishes our team from other medical device consulting firms.

Medical Device Design Expertise

When you partner with M.L. Reo Consulting, you can be confident we will see your project through from concept to commercialization. Our design and development team is dedicated to engineering your medical device to specification.

With over half a century of combined experience in the medical device industry, we’ve worked with a large portfolio of projects in many different medical fields including:

Cardiovascular
Structural heart
Orthopedic
Peripheral vascular
Neurovascular and Neurologic
Spinal Cord Stimulation
Ear, Nose, Throat (ENT)
Renal
Gynecologic
Sleep Apnea

Whatever your requirements, our medical device design and development team can assist you in making them a reality.

Need medical device consultants that get the job done?

Product Realization, Delivered.