Quality | Post-Market

A Smarter Way to Extend your Capabilities

There are a lot of quality consultants and quality management system providers out there to help 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 successfully resolved audit deficiencies by using our cross-functional supported quality services. 


More than just Quality Consulting.

What Makes Us Different

Vision for the Future

Our senior-level corporate experience, along with a proven track record of global product launches enables us to provide unique insights and solutions.

Knowedgeable & Pragmatic

Quality-related educational resources and continuous transfer of knowledge through personal mentoring set your quality team up for continued success.

Extension of Your Company

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

Vision for the Future

Knowedgeable & Pragmatic

Extension of Your Company

Our senior-level corporate experience, along with a proven track record of global product launches enables us to provide unique insights and solutions.
Quality-related educational resources and continuous transfer of knowledge through personal mentoring set your quality team up for continued success.
We supplement your quality organization at both the system and product levels enabling you to focus on growing your business.

Features


Life Cycle Management Activities

Life Cycle Management plays a vital role in maintaining and updating product documentation due to issues (i.e., supplier change notices, complaints, or CAPAs) which may trigger design or manufacturing changes.

Strategic Understanding

A perspective that doesn’t try to hit a square peg into a round hole and provides the right solution for your issues.

Cross-Functional Expertise

To help you see the big picture, we leverage our various in-house functional capabilities to assist and manage legacy product changes.

Ongoing Education

By participating on industry committees and workshops, we proactively fill your knowledge gap by translating the regulations into meaningful actions.

Strategic Understanding

Cross-Functional Expertise

Ongoing Education

A perspective that doesn’t try to hit a square peg into a round hole and provides the right solution for your issues.
To help you see the big picture, we leverage our various in-house functional capabilities to assist and manage legacy product changes.
By participating on industry committees and workshops, we proactively fill your knowledge gap by translating the regulations into meaningful actions.

Auditing with Perspective

Our cross-functional expertise allows us to assess internal quality systems and third party quality systems before making strategic business decisions.

Comprehensive Approach

We can use our expertise to provide a comprehensive audit before an external regulatory body finds deficiencies allowing you to address gaps in a proactive manner.

Strategic Understanding

We can provide unique insights from a global perspective when evaluating strategic Mergers and Acquisitions, as well as Licensing opportunities.

Extension of Your Team

We act as an extension of your supplier management organization in order to address increased scrutiny of outsourced supplier activities. 

Comprehensive Approach

Strategic Understanding

Extension of Your Team

We can use our expertise to provide a comprehensive audit before an external regulatory body finds deficiencies allowing you to address gaps in a proactive manner.

We can provide unique insights from a global perspective when evaluating strategic Mergers and Acquisitions, as well as Licensing opportunities.

We act as an extension of your supplier management organization in order to address increased scrutiny of outsourced supplier activities. 


Quality Consulting

When the regulatory environment is uncertain, choose industry experts who have walked in your shoes to resolve regulatory agency life cycle management issues.

Strategic Leadership

When an organization's leadership team faces strategic decisions, we provide key quality learnings and recommendations with a cross-functional perspective.

Diverse Experience

Experience within multiple, global corporations brings a proven track record of execution at a process, product, and organizational level.

Two in One

Quality experts with regulatory experience in strategies, submissions, and agency interactions which augment the Quality Services with an invaluable perspective.

Strategic Leadership

Diverse Experience

Two in One

When an organization's leadership team faces strategic decisions, we provide key quality learnings and recommendations with a cross-functional perspective.
Experience within multiple, global corporations brings a proven track record of execution at a process, product, and organizational level.
Quality experts with regulatory experience in strategies, submissions, and agency interactions which augment the Quality Services with an invaluable perspective.

"EdgeOne Medical implemented an intuitive, 14971 Risk Management Process that should be considered Best in Class."

Sr. Manager, Fortune 1000 Pharma/Medical Device Company

+ Quality

Because EdgeOne Medical manages your Life Cycle Management needs, you get more out of each service when they work together.

+ Regulatory

Have more confidence managing your product and quality system 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 design and risk management files.

+ Project Management

Get valuable insights on your timelines and better understand potential risks.

+ Regulatory

+ Testing

+ Project Management

Have more confidence managing your product and quality system within the guard rails of quality and regulatory.
Discuss alignment of quality system requirements with proposed testing, and understand how test data influences your design and risk management files.
Get valuable insights on your timelines and better understand potential risks.

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