BREAKING: Groenakker Achieves ISO 13485:2016 for Advisory & Test Subcontracting Services

About Us

WE ARE
Groenakker

[ɡroʊnˌɑkər] Dutch. adj.

Fertile ground for growth and innovation. A nurturing environment for creativity to flourish and collaboration to take hold.

Groenakker team collaboration representing partnership and innovation in medical device testing

The Groenakker team has an extensive background in a multitude of scientific, engineering, quality and regulatory areas within the medical device industry. Our work focuses in key scientific and technical areas where companies of all sizes face significant challenges in bringing innovative products to market.

Groenakker was founded on the simple principle that safety in Life Sciences matters. Our business is to meet our client's needs efficiently and cost effectively.

QUALITY

With our recent ISO 13485:2016 accreditation, we continue to show commitment to upholding the highest standards for compliance in the medical device industry and test. Our robust quality management system ensures safety, precision, and regulatory compliance in every advisory and test subcontracting service we provide. From biocompatibility to toxicology, we deliver reliable, high-quality solutions that accelerate your path to market. Based in Philadelphia and Chennai, we're proud to support global innovators with expertise you can count on—because for us, quality isn't just a goal, it's the foundation of everything we do.

ISO 13485:2016 Quality Management System Certificate from Intertek for Groenakker LLC

VALUES

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EXCELLENCE

Nothing else matters if the solution which is born with deep knowledge and experience & executed with clear organization and clarity. In all things we strive to be excellent, such that when a client works with Groenakker they can have confidence that they are receiving the best possible services that can be offered.

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SPEED

Quality takes time, this is true. That is why we've spent years developing processes and systems to allow for rapid on-demand execution. No one wants to be second to the market. Groenakker to get your work solved quickly & your products to market faster.

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CREATIVITY

The application of regulations is as comparable as the types of medical products which enter the marketplace. Creativity is a core requirement while maintaining clients achieve standards of patient safety and regulatory conformity. By working with Groenakker you're engaging experts with creativity to bring about effective solutions.

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GLOBAL READINESS

Groenakker is a global organization with a workforce which ensures our client's products are every time distributed. Whether we are providing local support for a regulatory audit or if a 24-hour work project complete needed, we leverage our global network to bring unique value on a worldwide scale.

VISION & MISSION

VISION

Championing the future of healthcare, where visionary medical device innovations empower individuals and communities to thrive in a vibrant, healthy world.

MISSION

To empower medical device innovators with expert technical and scientific advisory services, fostering solutions that revolutionize healthcare and improve patient outcomes. We are committed to excellence, integrity, and collaboration, harnessing our deep industry expertise to navigate complex challenges and drive transformative advancements for the betterment of global health.