Compliance Team is here to help your team to minimize risk and complexity when it comes to your quality systems, validation programs and regulatory and compliance excellence.

Our compliance consultants work to bring lifesaving products to market.  By teaming up with our trusted experts, your company gains the confidence that your medical product design, clinical research operations, or manufacturing & validation processes meet FDA regulatory & compliance standards at every stage of development.  Connect with our Solutions Team

Minimized Risk

Meet and exceed product safety expectations for your customers, stakeholders and the FDA.

Guided Focus

Having the right information and experts helps you focus on what's most important

Trusted Partnerships

You can count on us to be with you every step of the way to help your team succeed.

Proven Results

We have helped over 200 companies to meet or exceed domestic and international regulatory standards.

Manufacturing a drug or medical device?

No matter how large or small the project, Compliance Team is ready to manage the regulatory details throughout your medical product life cycle.

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Get insight into the FDA . Download the Top 483s of 2021

We’re here to minimize risk and complexity.

Our solutions allow your company to focus on growing your business without delays or interruptions due to regulatory requirements. For almost 20 years, our compliance consultants have worked to bring lifesaving products to market. What could your company accomplish if it had a partner like Compliance Team?
  • Your team [Compliance Team] helped us build a streamlined, and compliant Quality System Manual. You assured our company was meeting both ISO and FDA standards. Compliance Team was an asset to our team during the ISO 13485 audit. Because of [Compliance Team's] your guidance and attention to detail, we obtained ISO 13485 certification and we were able to expand our medical device manufacturing services and customer base.
  • "The Compliance Team group has been instrumental in helping us with all aspects of our compliance to 21 CFR part 820 and part 11.  We sincerely appreciate their level of expertise, their patience and their integrity as they guided us through interpretation of the medical device and data integrity regulations.  I would recommend them to anyone needing practical advice on these topics." 
    Anita, Regional Director of Quality
  • “…Compliance Team was credited for having the flexibility to understand the repercussions of various risk-based options, assuring qualification coverage via a less-restrictive method.”
  • “Compliance Team was also instrumental in authoring the Quality Plan, a Validation Master Plan, Validation Plans, Validation Risk Assessments, and the Validation Project Plan for all of these systems…”
  • Thanks again for all your help, we hope to continue working with Regina as much as we can, she has been a perfect fit for us.
    Jamie O’Neil
    CEO, Electroskip

Regulatory and Compliance Resources

CT CEO, Michelle Bonn, wins Groundbreaker Award from MedTech

Michelle Bonn, President and CEO of Compliance Team, was presented the MedTech Association’s 2021 Groundbreaker Award on January 13th at the del Lago Resort in Waterloo, New York. MedTech Association holds this annual event to “celebrate New York’s bio/med industry and recognize the innovators who are driving the state’s life sciences ecosphere”. Also recognized at the […]

FDA Seeking Comment on 3D printed Medical Devices

The FDA is seeking comment on 3D printed medical devices, in its Discussion Paper. 3D Printing Medical Devices at the Point of Care: Discussion Paper | FDA From this Discussion Paper, it is clear that the FDA is interested in understanding how to implement policy on this cutting-edge assortment of medical devices that have very […]

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Latest News

Compliance Team Earns WBENC Credentials

For Immediate Release: 11/1/2021 [Buffalo, New York] - Compliance Team is proud to announce its re-certification as a woman owned enterprise by the

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