Covita Health Partners, a newly launched regulatory and quality consulting firm, is proud to announce its entry into the life sciences industry by offering expert, affordable support to innovators developing medical devices, diagnostics, digital health technologies, combination products, human tissue-based therapies, and more. With a focus on accessibility, creativity, and measurable value, Covita is redefining what it means to be a consulting partner in today’s dynamic healthcare environment.
Founded to Fill a Critical Gap
Covita Health Partners was founded in response to a growing and urgent need in the market. Life science innovators, especially early-stage teams, are being asked to do more with fewer resources, yet access to experienced, practical regulatory and quality support remains limited. Without that support, promising products face costly delays, missed opportunities, and in many cases, never reach the patients who need them most.
“In this industry, timing and execution are everything,” said Jeff Dupont, Chief Executive Officer and Co-Founder of Covita Health Partners. “We started Covita because we saw talented teams and groundbreaking innovations stalling, not for lack of vision, but for lack of the right guidance at the right time.”
The stakes are high: 75% of medical device startups fail, and the statistics are not much better in other segments of the life sciences. Covita Health Partners is committed to changing that. By providing smart, flexible support, and crafting creative, resource-conscious strategies, Covita helps innovators overcome early obstacles, accelerate development, and stay on a clear path to market.
Industries Served and Services Offered
Covita Health Partners supports clients across the life sciences spectrum, including:
- Medical Devices
- In Vitro Diagnostics (IVDs)
- Digital Health & AI-enabled technologies
- Combination Products
- Human Tissue-Based Products
- Reproductive Medicine
- Wellness Products and Supplements
Its service offerings span the entire product lifecycle, some of which are listed below:
- Regulatory strategy and submissions (e.g., 510(k), De Novo, PMA, Q-Sub, CE marking, MDL)
- Quality management systems and ISO 13485 readiness
- Design control and risk management
- Software lifecycle and cybersecurity compliance
- Supplier qualification and management
- Audit readiness and inspection support (including PAI and ISO audits)
- Postmarket surveillance, complaint handling, and change control
A True Partner, Not Just a Service Provider
Unlike traditional consultants that offer one-size-fits-all services, Covita takes a tailored, hands-on approach. Its team engages as a true partner and scales support to match the client’s stage and structure, and provides mentorship, training, and flexible solutions that grow with the organization.
“We’re not just here to tick boxes,” said Dupont. “We’re here to solve problems creatively, teach as we go, and make sure our clients understand not only what they need to do, but why. That’s how you build long-term success and foster long-term relationships.”
Delivering Real, Measurable Value
Covita’s approach is designed to drive impact where it matters most. Clients benefit from:
- Faster time to market through proactive planning and targeted execution
- Reduced risk by staying ahead of regulatory requirements
- Smarter spending through right-sized systems and support
- Stronger investor confidence thanks to clear, executable strategies
- Empowered teams with increased internal capability and confidence
Accessible Expertise for a Healthier Future
Whether preparing for your first FDA submission, entering the EU market, or scaling operations after securing funding, Covita Health Partners brings clarity, experience, and creativity to the table, without the inflated cost or inflexibility of traditional firms.
“At Covita, we believe innovation shouldn't be held back by access to regulatory and quality support,” said Dupont. “Our mission is to close that gap, so innovative medical products can reach the patients who need them.”
For more information, visit https://www.covitahealthpartners.com/ or contact Covita Health Partners at info@covitahp.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250805781605/en/
“We started Covita because we saw talented teams and groundbreaking innovations stalling, not for lack of vision, but for lack of the right guidance at the right time."
Contacts
Covita Health Partners
Emily Becker
beckere@covitahp.com
607-351-0062