FDA Regulatory Compliance

FDA Regulatory and Compliance Consulting

Introduce your medical device to the US market smoothly with expert help in FDA regulatory affairs and compliance. 


What is the role of the FDA in marketing your medical device?

The FDA is a consumer protection government agency that aims to promote and protect health.  

Its branch, The Center for Devices and Radiological Health, is responsible for the monitoring, approval and clearances of medical devices and in vitro diagnostics as well as overseeing the manufacturing, performance and safety of these devices. CDRH’s main role is to: 

  • Evaluate the safety and effectiveness of medical devices before and after release to the market 
  • Ensuring that patients and providers have timely and continuous access to medical supplies 

The manufacturers of medical devices, including software, should follow requirements covered under the 21 Code of Federal Regulations (CFR), 800 series, which describes rules set forth to ensure that medical devices are safe and effective.  


How can we help you release your medical device to the market under the FDA’s regulations?

We cooperate hand in hand with you to work out the best possible solution to support your business case, implementing best practices and state-of-the-art technologies, while keeping a patient first-approach. 

How can you benefit from our consulting services?


Shorter time to market

Launch your product smoothly into the US market.


Lower project risk

Avoid unnecessary and costly delays.


Lower regulatory risk

Don’t worry about product recalls or fines due to nonconformities.


Product market strategy optimisation

Ensure you have the most effective strategy to launch your product in various markets. 


Regulatory vigilance

We’ll keep you posted about any important regulatory updates.

Our process

Get expert assistance with FDA regulatory compliance at every stage of your product’s lifecycle.

Ideation – Execution – Commercialisation – Post-market – End of life



  • Preparation of the most effective product regulatory strategy for the US market: 510(k), DeNovo, PMA, Breakthrough Device Designation, or any other:
    • Advising on developing valid scientific evidence
    • Providing guidance on compliance-related activities
    • Support in classifying your device and choosing the right predicate
  • Identification of applicable requirements
  • QMS implementation according to Title 21, part 820

Product execution

  • Product development from MVP and prototype up to final product
  • Advice in choosing and documenting appropriate testing
  • Developing product documentation


  • Pre-submission preparation and advice
  • Submission preparation
  • Assistance in Additional Information Requests
  • Responding to any interactive review questions
  • Help in addressing any comments/OFIs/ non-conformities

Post-market phase

  • Advice on conducting post-market surveillance activities
  • Support in assessing changes to the existing device
  • Providing guidance on introducing another variant of an existing device – advising on systems, procedure packs or device modifications


What is the scope of our FDA regulatory and compliance consulting services?

  1. We provide advice at every level – from a high-level strategy to detailed process and technical requirements.
  2. You can entrust us to prepare quality technical documentation and submission documentation for your product or group of products.
  3. We assist in implementing quality processes, including risk analysis.
  4. Have us audit your medical project and check its readiness for submission.
  5. We organise workshops and trainings for your team.
  6. Our recipe for success is that we’re always up to date with the latest changes to the regulations, on which we base all our decisions and recommendations combined with our extensive experience in the industry.

Check out our other services for the healthcare industry.


18+ years

of professional practice

200+ medical products

launched successfully

50+ countries

where we introduced medical products

Meet our expert

Working for the MedTech sector allows me to continuously challenge myself

Krzysztof Minicki
Director of Healthcare & Life Sciences

I’ve been developing software for as long as I can remember. I started as a developer and migrated through many different roles in various IT projects. The knowledge and experience I gained allowed me to achieve a comprehensive understanding of the software development process and tailor it to clients’ needs. I’ve been using this skill for the past few years, i.e. when building medical products. I know how to swiftly and effectively develop software addressing all current regulations that’s both safe for patients and will provide them with tangible benefits.

Krzysztof Minicki

Contact us

Get expert assistance in releasing your medical product under FDA regulations

Krzysztof Minicki

Krzysztof Minicki

Director of Healthcare & Life Sciences

+48 600 039 611

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