With a steadfast commitment to quality and scalability, we offer unparalleled expertise across all regulatory pathways, helping our partners expand into new markets, broaden their geographic reach.
Clinical segments we serve
At Evergen, our deep clinical knowledge and biomaterial expertise allow us to identify the most effective biomaterial solutions for a diverse set of clinical applications.
- Plastic & Reconstructive Surgery
- Dental
- Ear, Nose, Throat (ENT) Surgery
- Sports Medicine & Orthopedics
- Hernia
- Ophthalmology
- Neuro/Spine
- Colorectal
- Wound Care
- Cardiovascular
- Urogynecology
Our manufacturing capabilities in regenerative medicine are built on state of the art facilities and proven techniques that enable the scalable production of biomaterial solutions. We adhere to Good Manufacturing Practice (GMP) standards to ensure quality and consistency in every batch. Our expertise includes end to end value chain services for multiple biomaterials. With robust and flexible manufacturing processes, we meet regulatory standards and deliver high-quality regenerative products to the market.
End-to-End Capabilities
At Evergen, we leverage deep industry expertise and a customer-centric approach to quickly and uniquely solve the challenges you face. With highly experienced R&D and clinical teams, we excel at developing innovative concepts that not only meet your needs but are also achievable from both a manufacturing and regulatory perspective.
We partner with you from the ground up, starting with a comprehensive understanding of your requirements. By evaluating the best platforms, form factors, and processes, we work together to design the optimal solution. Our collaborative approach ensures we deliver a clinically viable, commercially successful solution with a focus on quality and consistency at scale.
Evergen’s capabilities extend across the entire product lifecycle. We specialize in navigating complex regulatory pathways, from securing approvals for biomaterials and product classifications to managing global market entry, geographic expansion, and maintaining compliance. With extensive experience in 361 HCT/P, 510(k), IDE, and CE marking, we provide the necessary documentation and testing to support your commercialization needs.
Evergen provides end to end solutions to ensure your success by combining cutting-edge design, robust manufacturing capabilities, and regulatory expertise—all backed by a commitment to delivering high-quality, safe, and effective solutions.
Additional Capabilities
We are continuously expanding our capabilities to better serve our OEM customers with specific needs. Our focus is on collaborating with customers around Evergen’s expertise in complementary areas with a commitment to innovation and efficiency.
- Allograft sourcing and screening and medical release
- Valve sewing and manufacturing
- Packaging & Distribution
- Xenograft sourcing and screening
- Concept prototyping and testing
- Regulatory Pathways (361 HCT/P- EU CE Mark, PMA, 510k)
- Processing (Safety and Sterilization)
- Molecular and biochemical assays
- QA/QC lot release testing
- Processing/Forming (Molding, lyophilization, perforations, crosslinking etc.)
- Biocompatibility Assessments and assays
- Third party logistics
Commercial-Ready Options
For those seeking an optimized path to market, we offer commercial-ready implants available as white-label or with customer-branded packaging. This provides a flexible solution—whether as a long-term outsourced option or a short-term interim choice while we collaborate on developing new and innovative products. Please note, product and implant availability may vary by country due to regulatory requirements. For details on specific product availability in your region, please consult your local representative.
Advancing regenerative biomaterial solutions.