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We're here to help.

IUVO Consulting, LLC offers excellence in international regulatory and quality compliance.


Contact Us Now!

Contact us today for compliance and regulatory strategy management assistance.

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How Can We Help You?

Regulatory Strategic Planning

Audit Support

ISO 13485 Compliance



Health Canada Medical Device Establishment License

EU Medical Device/IVDD CE Marking


Pre-Submission Meetings

510(k)/de novo Pre-Market Notifications



About Us

At IUVO Consulting, LLC, the phrase “We’re Here to Help” is more than a mere slogan. Our name – “iuvo” – is the word for “help” in Latin, and it is the hallmark around which our organization has been built. For more than 50 years combined, our consultants have worked with leaders and organizations around the world, helping them achieve their strategic and compliance goals. Hundreds of companies have sought and received our help to successfully navigate complicated international regulatory requirements and to devise effective regulatory strategies ranging from simple to extremely complex.

The road to regulatory compliance can be fraught with red tape and gray areas. At IUVO Consulting, we bring clients a comprehensive understanding of international standards and regulations for medical devices to help them avoid common pitfalls. We believe strongly that by listening to our clients, we gain important insights into their organizational and regulatory needs. Using that information and our expertise, we work closely with our clients to design effective solutions to the challenges they face. Whether via electronic conference or on-site collaboration, we help companies evaluate their current regulatory state, assess the needs and skills of their regulatory leaders, and develop strategies that allow them to achieve and maintain regulatory and quality compliance.

At IUVO Consulting, our core value is "Providing Excellent Service to Our Clients." We realize that every company’s organizational, leadership, and regulatory needs are unique; thus, every solution we propose is tailored to meet the specific needs of each one. We place high importance on building long-term relationships with our clients that stand firmly on trust, honesty, and effective communication. Our clients can be assured that we will not waste their time or resources.

Ultimately, we believe that we are here to serve the global medical device industry. Therefore, at IUVO Consulting, LLC, we commit to treat all with the highest levels of professionalism, integrity, and kindness, and we will always go above and beyond to meet the needs of our clients. Whether your project requires a few weeks or many months, we at IUVO Consulting, LLC pledge to support your firm every step of the way.

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