Quality | Remediation

Quality services that are in concert with Product Development.

Does your organization struggle with legacy product Design History Files (DHF) not complying with current regulatory requirements? Prioritization and Resourcing conflicts often emerge between product development and product remediation projects. DHF remediation requires a commitment to resources, appropriate procedures, a project leader, a thorough understanding of options, and a strategy to tie it all together. If this sounds familiar, let us show you how EdgeOne can become an extension of your company.

More than just Quality Consulting

What Makes Us Different?

Knowledgeable and Pragmatic

Quality-related educational resources and simplicity of thought allows for derived solutions that align with your current realities and future goals.

Extension of Your Company

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

It's All Connected

Understanding how interdependencies exist within the DHF and connecting all the interfacing information together is strengthened by our cross-functional understanding.

Knowledgeable and Pragmatic

Extension of Your Company

It's All Connected

Quality-related educational resources and simplicity of thought allows for derived solutions that align with your current realities and future goals.
We supplement your quality organization at both the system and product levels enabling you to focus on growing your business.
Understanding how interdependencies exist within the DHF and connecting all the interfacing information together is strengthened by our cross-functional understanding.

Features


Remediation

Risk-based remediation strategies that balance our cross-functional experience and regulatory requirements against your company’s unique objectives and goals. We have successfully remediated numerous medical device and combination product Quality Management Systems, Design History Files, and Risk Management Files by providing practical strategies and executing on our approach.

Cross-Functional Resource Extension

EdgeOne's knowledge and experience in product development allows us to create DHFs that meet the requirements of 21 CFR 820.30, ISO 14971, and ISO 13485 requirements.

Cost Savings

We can save you costs by determining the best option to achieve your desired end goal, whether it be working on-site or functioning in a remote capacity.

Living Strategy

We can help you save time and cost by ensuring your risk-based strategy remains valid as you continue with remediation, considering changes in the regulatory environment.

Cross-Functional Resource Extension

Cost Savings

Living Strategy

EdgeOne's knowledge and experience in product development allows us to create DHFs that meet the requirements of 21 CFR 820.30, ISO 14971, and ISO 13485 requirements.
We can save you costs by determining the best option to achieve your desired end goal, whether it be working on-site or functioning in a remote capacity.
We can help you save time and cost by ensuring your risk-based strategy remains valid as you continue with remediation, considering changes in the regulatory environment.

+ Quality

Because EdgeOne Medical can manage all your Remediation needs, you get more out of each service when they work together.

+ Regulatory

Have more confidence remediating 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 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 remediating 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 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