Medical Device Regulatory Consulting

Your Cost Effective and Timely Path to Market Approval

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About Medical Device Regulatory Consulting

You have a concept or are actively developing a medical device technology with market potential.
What's next? Making sure there is a clear regulatory plan for obtaining FDA approval. Our knowledgeable and experienced team will assess the regulatory requirements for your specific device and create the most expedient and cost effective regulatory path to support your business plan.
The belief that the FDA process is unmanageable and adversarial is a myth. Our team will quickly initiate communications with FDA to assure a positive and collaborative process.
Contact us to learn more about how our multidisciplinary team can help your company.

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Why Med Tech Companies Large and Small Hire Medical Device Regulatory Consulting

The technical experts at your company have worked hard to develop a product to meet a need in the healthcare market. Working as your partner, our team translates their work product into a regulatory submission that will meet requirements specified by FDA. We understand the issues of current importance to FDA as the industry landscape rapidly changes with advances such as digital medicine and automated functionality (AI). We stay current on FDA requirements in a wide variety of medical specialties including:● Cardiology● Radiology● Orthopedics● Women's Health● Surgery● In Vitro Diagnostics
We apply the same principles to working with Notified Bodies to obtain the CE Mark.
The device development process is a substantial investment of company resources, whether for a new product of an updated version of an existing product. It is most efficient to integrate the regulatory activities as early as possible in the process to avoid gaps in performance data or the need to repeat costly testing.

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Why Businesses Hire Medical Device Regulatory Consulting

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Working with one multidisciplinary team eliminates the need for multiple external consultants
Working with a team that has vast experience in interacting with FDA is a game changer.
Working with a team with excellent communication skills expedites interactions with FDA.
Contact us to learn more about how Medical Device Consulting can help your company.

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Why Choose Medical Device FDA Regulatory Consulting

Working Together

Collaborating with you, making sure the FDA submission is well written, accurate and gets the results you want.

Professional Advice 

Professional advice for all types of performance testing including working with test laboratories for standards compliance on time and on budget.

Completed Projects on Time

Planning of efficient time lines and establishing key milestones to keep investors and stakeholders informed and engaged.

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We have obtained efficient and timely FDA results and CE Marking for multiple clients. To add your company to our list, fill out the form below to get started. 

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Headquarters

San Francisco, California

Phone

(650) 279-0668

Email

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Partial List of Clientele:

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© Copyright 2021 Medical Device Regulatory Consultant

Website Created by:

ProFusion Web Solutions

© Copyright 2021 Medical Device Regulatory Consultant