Not your average advisors. Integrated partners in your success.

gezellig

[heh-sell-ick] Dutch. adj.

a feeling of warmth, comfort and relaxation. a friendly ambiance and cozy atmosphere. pleasant togetherness.

How We Work

01 — Integrate

Many engagements start as a straight forward question or request for a tactical level of support with a struggle or challenge. While we strive to deliver on the specific need of our clients, it is also our goal to utilize these specific requests as an opportunity to come alongside our clients and understand their underlying needs, ensuring the solutions we provide do not only meet the challenges of today, but also act as a springboard for the future. Gezellig is synonymous with comfort, we do all we can in our work to promote a sense of partnership, blurring the lines between organizations and promoting a transparency which fosters creativity.

02 — Create

Medical device safety maybe is not an area which you’d typically associate with creativity. Our aim is always to bring a solution past the point of mere compliance-based thinking, and into truly meaningful solutions that are scaled appropriately for our client’s business’. Creating a bespoke approach to a problem in a strategic and creative manner is where we excel - endeavoring in all things to bring value to our customers which far exceeds our cost.

03 — Execute

The rest is just words, at the end of the day discipline in execution is the critical element which our customers have come to count on us for. There are no STAT fees or rush charges, your problems are our problems and we execute in such a way as to let you know that we bear your burdens and time constraints with you. No solution is worth while which shows up too late or haphazardly. We stand by our timelines. We stand by our work.

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About Us

Expertise.

Experience.

Determination.

 

Gezellig Scientific was founded on the simple principle that medical device safety matters. Our business is meeting our client’s needs. Whether in establishing complete processes and systems, or executing discrete analyses and assessments. We partner with our customers to ensure non-clinical safety & quality requirements are met efficiently and to the highest possible standards.

The team at Gezellig leverages best-in-class methodologies to clearly and concisely document and mitigate biocompatibility-related risks. Our goal is not merely to meet the requirements of ISO 10993-1 and related regulations and regulatory guidances, but to do so in a way which integrates seamlessly within an ISO 14971 risk management framework.

“Gezellig” is a Dutch word that does not have a direct English translation. It roughly means comfort or cozy. A pleasant togetherness if you will. Our approach is to integrate, create, and execute in a way that blurs the lines between our organization and yours to fully foster transparency and trust.

Gezellig Scientific has offices in the United States and Italy to serve our clients worldwide.

Face your medical device quality & safety challenges head on.