As a global Contract Development and Manufacturing Organization (CDMO), our collaborative and agile partnership model ensures that services are tailored to your needs.
We have an unwavering commitment to quality and reliability at scale and offer comprehensive expertise across the full spectrum regulatory pathways, enabling our customers to successfully enter new markets, expand their geographic reach, and ensure ongoing compliance.
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
- Sports Medicine & Orthopedics
- Neurosurgery
- Cardiac
- Dental
- Hernia
- Colorectal
- Urogynecology
- Ear, Nose, Throat (ENT) Surgery
- Ophthalmology
- Wound Care
Product Development
Evergen has deep industry expertise and a customer-centric culture that enables us to uniquely and quickly solve the challenge you want to address. We excel at developing a range of innovative concepts that meet your needs and are achievable from a manufacturing and regulatory standpoint.
With highly experienced R&D and clinical teams, deep material expertise, and continued innovation in pursuit of improved patient outcomes, we design and deliver commercially viable clinical solutions with an unyielding dedication to quality and consistency at scale.
All our partnerships begin by building a comprehensive understanding of your requirements and evaluating which platforms, form factors, and processes best achieve them. We then collaborate to develop the optimal design, manufacturing process, regulatory strategy, and distribution arrangement, ensuring the delivery of a commercially viable clinical solution.
Contract Manufacturing
Evergen has multiple state-of-the-art facilities and strictly adheres to redundant safeguards to give OEM customers, physicians, and patients confidence in the quality and safety of every implant.
Regulatory & Compliance
Evergen has a long history of helping companies secure regulatory approvals for a wide array of biomaterials and product classifications. We specialize in collecting post-market clinical evidence to support regulatory requirements for commercialization. Additionally, Evergen can manage regulatory approval pathways to enter markets, expand geographically, and maintain compliance. This includes providing the appropriate documentation and testing to navigate complex global regulatory pathways, including 361 HCT/P, 510(k), IDE, and CE marking.
Commercial-Ready Options
For those looking for an optimized path to market, commercial-ready implants are also available as white-label or with customer-branded packaging to provide a long-term outsourced solution, or a temporary short-term option while we partner on something new and novel. Product and implant availability may vary by country due to regulatory conditions. Please consult your local representative for information on the availability of specific products in your region.
Additional Services
Our expertise spans the value chain. We offer a suite of off-the-shelf products as well as a range of ancillary services, either as a standalone offering or add-ons to our CDMO partnerships. Our customer-centric ancillary services include tissue services & allograft donor screening, concept prototyping & testing, and third party logistics.
Evergen. Advancing regenerative biomaterial solutions.
Evergen. Advancing regenerative biomaterial solutions.
Evergen. Advancing regenerative biomaterial solutions.