As a trusted global Contract Development and Manufacturing Organization (CDMO), our flexible, collaborative approach ensures that every service is customized to meet the needs of our partners.
With a steadfast commitment to quality, safety, and scalability, we offer unparalleled expertise in regulatory pathways, helping our partners expand into new markets and broaden their geographic reach.
Our patient-first CDMO partnership model and clinical expertise allow us to deliver the most effective biomaterial solution in the ideal form for a diverse set of clinical applications including:
Plastic & Reconstructive Surgery
Sports Medicine & Orthopedics
Neuro/Spine
Cardiac
We also have expertise in:
We integrate advanced material science with scalable manufacturing processes to solve our customers’ most complex challenges. Our experienced R&D and clinical teams excel at turning regenerative concepts into practical solutions that meet functional, mechanical and regulatory standards for clinical use.
With capabilities to support the entire product lifecycle, we collaborate with our partners to build innovative solutions from the ground up, first understanding your goals, then evaluating the best platforms, form factors, and processes to meet specific clinical and procedural needs, ensuring quality, safety, consistency, and scalability at every step.
We specialize in navigating complex regulatory pathways, including securing approvals and product classifications, managing global market entry and geographic expansion, and maintaining compliance. With a robust ISO 13485 certified quality management system, and extensive experience in 361 HCT/P, 510(k), IDE, and CE marking, we provide the documentation, testing, and expertise to support your ongoing commercial success.
At Evergen, we keep it flexible — with capabilities across the value chain, we provide exactly what you need at the right time in your product development cycle.
Evergen Donor Services are experts in the tissue donation process, partnering closely with tissue recovery organizations to deliver surgical implants which transform patients’ lives.
