Ulmer Ventures
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Medical Device Regulatory Strategy 

 

Our Approach

 

We engage our clients to gain a deep and clear understanding of their needs.  This rigorous discovery process serves as the starting point to develop solutions that deliver for the client and meet the requirements of the regulatory agency.  Consultants use a consistent set of tools to solve your problems, consider an exhaustive range of factors to manage risks and unearth opportunities for the customer.

 

Contact

CONTACT

info@ulmerventures.com

+1 202.596.2492
 

 

Areas of Expertise


Strategy

Consultants develop a regulatory path that manages business risks and supports long-term company growth.

Compliance & Change Management

Ulmer Ventures consultants conduct an assessment of the regulatory and business risk and provide comprehensive solutions.  We proactively manage risks that accounts for patient safety, product quality, customer retention, on time delivery, and regulatory compliance. We provide concrete action plans to manage change in the form of reorganization, employee engagement, or crisis management.



FDA Communication

We prepare the company for effective interactions with FDA. We focus the interactions on getting the answers you need for clearance or approval.

Interim Executive Leadership

We offer short-term roles for senior consultants to deliver on specific key business needs.


Regulatory diligence

At Ulmer Ventures, experienced consultants evaluate potential acquisition targets for robust regulatory submissions, quality management systems, and compliance.

Training & Education

Experienced consultants build customized lectures to Universities and Corporations on topics related to medical device development. Our focus is on the practical realities involved in bringing a technology from concept to the production-level product. The training and educational opportunities are delivered through webinar, classroom setting or intimate round table format.

 
 
 

 
 
 

Let's Connect.

Use the form below to contact us regarding your needs. Please be as detailed as possible. Include your industry along with any specific document requests. To help us provide excellent service, we recommend that you first describe the issue you’re having before telling us what you want to achieve. You may also email to make an appointment.

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Please do not include confidential or sensitive information in your message. In the event that we are representing a party with opposing interests to your own, we may have a duty to disclose any information you provide to our client.