Quality | Pre-Market

A Smarter Way to enable your Business.

There are a lot of quality consultants and quality management system providers out there to help develop and manage your quality system, but do they provide quality solutions that are tightly connected to regulatory requirements and your unique business goals & constraints?  Last year EdgeOne Medical clients saved 20% by using our cross-functional supported quality services.

More than just Quality Consulting.

What Makes Us Different?

Knowledgeable & Pragmatic

Our breadth of experience with companies large and small enable us to continuously transfer knowledge that is innovative, pragmatic, and right-sized.

Extension of Your Team

We supplement your quality organization at both the system and product levels enabling you to focus on growing your business.

Cross-functional Approach

Throughout the development process we leverage our various in-house functional capabilities to enhance our Quality Services.

Knowledgeable & Pragmatic

Extension of Your Team

Cross-functional Approach

Our breadth of experience with companies large and small enable us to continuously transfer knowledge that is innovative, pragmatic, and right-sized.
We supplement your quality organization at both the system and product levels enabling you to focus on growing your business.
Throughout the development process we leverage our various in-house functional capabilities to enhance our Quality Services.

Features


Acting Quality Representative

Whether you are an early-stage company or a company going through an organizational transition, our experienced quality team members can support your quality representative needs and avoid unnecesary business interruption.

A Strategic Voice

A service that doesn’t just fill the quality role but also enhances your understanding of the importance quality plays within your organization.

Pragmatic, Risk-Based Options

When your quality resource may not be available or lacks situational experience, we work quickly to understand your goals and identify risk-based quality options.

Built-In Education

Throughout the product realization process we deliver vital on the job training for quality activities saving you time and money.

A Strategic Voice

Pragmatic, Risk-Based Options

Built-In Education

A service that doesn’t just fill the quality role but also enhances your understanding of the importance quality plays within your organization.
When your quality resource may not be available or lacks situational experience, we work quickly to understand your goals and identify risk-based quality options.
Throughout the product realization process we deliver vital on the job training for quality activities saving you time and money.

Quality Systems to Enable Development

By understanding your product development strategy and by leveraging our in-house quality experts and system, we can quickly move development efforts ahead.

Flexible and Time-Sensitive

We can operate within your system, our 13485:2003 certified process, or a combination of both, to develop your product and save valuable time.

Product Development Experts

Our expertise helps make sense of the nuances between risk management and design control requirements, offering an intuitive approach for ease of implementation.

Comprehensive and Unique Approach

Our cross-functional perspective allows us to proactively build an integrated, risk-based solution that links development through lifecycle management.

Flexible and Time-Sensitive

Product Development Experts

Comprehensive and Unique Approach

We can operate within your system, our 13485:2003 certified process, or a combination of both, to develop your product and save valuable time.
Our expertise helps make sense of the nuances between risk management and design control requirements, offering an intuitive approach for ease of implementation.
Our cross-functional perspective allows us to proactively build an integrated, risk-based solution that links development through lifecycle management.

"EdgeOne Medical provided a comprehensive and very compelling Quality System solution for my early-stage Medical Device company.  I think they have solutions that every Medical Device early-stage venture should consider."

Avi Roop, Co-Founder & CEO Miret Surgical

Quality +

Because EdgeOne Medical integrates your Product Development Services, you get more out of each component when they work together.

+ Regulatory

Have more confidence developing your product within the guard rails of quality and regulatory.

+ Testing

Discuss alignment of quality system requirements with proposed testing, and understand how test data influences your risk management file.

+ Project Management

Collaboratively integrate a phased quality system approach from development through launch.

+ Regulatory

+ Testing

+ Project Management

Have more confidence developing your product within the guard rails of quality and regulatory.
Discuss alignment of quality system requirements with proposed testing, and understand how test data influences your risk management file.
Collaboratively integrate a phased quality system approach from development through launch.

Questions?

Speak with a Product Development Specialist to learn more about our services.

Call 1-312-300-6640

Request a Consultation

Schedule a consultation with one of our experts about your specific needs.

Get Knowledge

Get answers and insights on the product development process from experts.

Access Blog

Questions?

Request a Consultation

Get Knowledge

Speak with a Product Development Specialist to learn more about our services.

Schedule a consultation with one of our experts about your specific needs.

Get answers and insights on the product development process from experts.

Call 1-312-300-6640
Access Blog