Innovenn is a boutique medtech consultancy for SaMD, Human Factors, and Regulatory Approvals in the US, EU & UK.
To optimize patient care and improve outcomes, Innovenn works to build patient-centered SaMD digital health solutions. With more than 125 years of combined expertise, we provide a potent mix of abilities and skills to design, develop, validate, and secure regulatory approvals for innovations that enhance patient health.
From pre-submission preparations to successful marketing of medical devices, we’ll guide you through the complex approval process for new medical devices.
Offering a comprehensive suite of Human Factors and Usability Engineering services that can be utilized throughout the product life cycle, from user-centered design consulting and early-stage iterative testing, to summative validation testing and regulatory Human Factors Compliance support.
A successful regulatory strategy is one that aligns not only with the requirements for data evidence to secure approval but is also integrated with the business, clinical and commercial strategies for positioning the product in the target markets.
With 300+ IND, NDA, 510(k), De Novo, and PMA submissions, we’ve helped get new drugs, devices and medical software devices (SaMD) into providers hands to improve patient outcomes.
Our consultants will help get your new drug approved by the FDA.
Effective program and technical management is crucial to successfully advancing health innovations in drug, medical devices, software as a medical device (SaMD), and digital therapeutics development. Learn how Innovenn’s team can help.
The highest standards must be maintained during medical device research, development, manufacturing, and testing to ensure optimal patient care and assistance. This goal of patient care is governed by quality standards which can be implemented with a robust quality management system (QMS).
Our network of seasoned consulting professionals have extensive experience in the pharmaceutical, medical device, and SaMD space. Our Subject Matter Experts (SMEs) can assist with strategic development, regulatory guidance, and other specialized support to align with your unique requirements and corporate goals.
Global reach from Wisconsin HQ. Serving clients in the US, EU, UK & Canada
6410 Enterprise Lane
Suite 230
Madison, WI 53719
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