Regulatory | Post-Market

There are many regulatory consultants who can step in and assist with your regulatory needs, but are they able to see beyond the immediate need and assess/guide you beyond the next week or month?  At EdgeOne Medical we can help you understand which regulations apply to you and how to comply with them as well as foresee upcoming relevant regulatory topics.

 

More than just Submission Assessments.

What Makes Us Different?

Two in One

Regulatory experts with Quality experience in processes and systems augment the Regulatory Services with an invaluable perspective.

Strategic Mindset

Our experience with various product types and classifications enables us to continuously transfer regulatory knowledge that is innovative, pragmatic, and right-sized.

 

Extension of Your Team

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

Two in One

Strategic Mindset

Extension of Your Team

Regulatory experts with Quality experience in processes and systems augment the Regulatory Services with an invaluable perspective.

Our experience with various product types and classifications enables us to continuously transfer regulatory knowledge that is innovative, pragmatic, and right-sized.

 

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

Features


Regulatory Intelligence

The success of your business depends on the ability to keep up with ever changing global regulatory requirements.

 

Global Knowledge

Our global experience can help identify multiple market requirements and determine how they fit into your development plan to minimize duplicative efforts.

Relevant and Clear

Interpreting and applying regulations can be difficult. Our years of experience with federal, state and foreign regulations can identify relevant requirements.

Aware of Trends

We participate in industry meetings and knowledge-sharing events to stay up to date with trends and upcoming changes to better prepare your business.

Global Knowledge

Relevant and Clear

Aware of Trends

Our global experience can help identify multiple market requirements and determine how they fit into your development plan to minimize duplicative efforts.
Interpreting and applying regulations can be difficult. Our years of experience with federal, state and foreign regulations can identify relevant requirements.

We participate in industry meetings and knowledge-sharing events to stay up to date with trends and upcoming changes to better prepare your business.


Change Assessment

As your business grows, you need to know if  the changes to your product or systems require new or additional regulatory activities.

Cross-Functional Opinion

Our Regulatory experts have Quality experience and identify quality impacts within your proposed changes.

Process Insight

We are familiar with development and life cycle management to know where assessments should take place within your processes.

Enterprise-Wide

Our regulatory assessment expertise extends beyond product submission and includes systems, processes. and advertising and promotion pieces.

Cross-Functional Opinion

Process Insight

Enterprise-Wide

Our Regulatory experts have Quality experience and identify quality impacts within your proposed changes.
We are familiar with development and life cycle management to know where assessments should take place within your processes.
Our regulatory assessment expertise extends beyond product submission and includes systems, processes. and advertising and promotion pieces.

Regulatory Operations

Regulatory Affairs, like other functions, requires processes and policies to operate smoothly within your organization.

Organized Information

Regulatory documentation is just as important as your Design History File.  We help you implement a structure to associate regulatory documentation with your product quality records while keeping them separate.

Submission Publishing

Regulatory agencies require submissions to contain specific format and content. We have experience with numerous filings for various agencies and can author and publish your submission.

Functional Integration

Regulatory input is important  for product development and business strategy. Our experience as funcitonal business leads helps you identify and integrate responsibilities to ensure true cross-functional participation.

Organized Information

Submission Publishing

Functional Integration

Regulatory documentation is just as important as your Design History File.  We help you implement a structure to associate regulatory documentation with your product quality records while keeping them separate.
Regulatory agencies require submissions to contain specific format and content. We have experience with numerous filings for various agencies and can author and publish your submission.
Regulatory input is important  for product development and business strategy. Our experience as funcitonal business leads helps you identify and integrate responsibilities to ensure true cross-functional participation.

Regulatory +

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

+ Project Management

Get valuable insights on your timelines and better understand potential risk points.

+ Quality Systems

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

+ Testing

Understand how new testing affects your product profile.

+ Project Management

+ Quality Systems

+ Testing

Get valuable insights on your timelines and better understand potential risk points.
Have more confidence assessing your product changes within the guard rails of quality and regulatory.
Understand how new testing affects your product profile.

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