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In this insightful testimonial, Clarissa Archer, a Quality Engineer at Harmonic Bionics, shares her experiences in navigating FDA inspections with confidence. She emphasizes the ease of organizing and presenting critical documents, highlighting how this streamlined process has enhanced efficiency and transparency in regulatory compliance. The video subtly reveals the role of Unifize in empowering quality management, offering a genuine perspective on its practical impact in the medical device industry.

How I got my MedTech company to comply with FDA Part 820 in 4 weeks

Customers

Denis's experience with Unifize: Revolutionizing quality assurance systems

Quality expert Denis details his transformative journey with Unifize. He praises its efficient design, user-centric approach, and the system's ability to streamline data handling and accelerate time to market.

Customers

Harmonic Bionics and Unifize: A seamless transition to regulatory compliance

Clarissa Archer shares her experience integrating Unifize into Harmonic Bionics, underscoring its value in streamlining change control, facilitating communication, and ensuring robust documentation for regulatory compliance in the medical device sector.

Customers

Engineering efficiency with Unifize: Michael Hogan's insights from Harmonic Bionics

Mechanical Engineer Michael Hogan elaborates on how the integration of Unifize at Harmonic Bionics has streamlined his engineering processes, promoting transparency and rapid turnaround in the medical device domain.

Customers

Here’s how Biovation Labs reduced testing costs from $146K to $65K in two months

Learn how and why Biovation Labs, an FDA regulated nutraceutical manufacturer based in Salt Lake City, took the decision to transition from MasterControl to Unifize for their product lifecycle (PLM) and quality management (QMS) processes.

A quote from Tedd Carr
Customers

How a quality veteran from boosted issue closure time by 75% within the first month

Tedd Carr from The Will-Burt Company discusses overcoming their diverse and complex quality challenges across various sectors with Unifize. By consolidating five systems into one, they achieved clear accountability and reduced issue closure from months to days, demonstrating significant efficiency gains and faster decision-making in their quality processes.