A new era of Regenerative Innovation

Pioneering the future of healthcare

HCM Medical, is the destination for cutting-edge contract manufacturing in the field of medical innovation.

We are a proven partner in the production of biological and biomaterial-based products, combining cleanroom expertise, advanced processing technologies, and regulatory know-how.
From human and animal tissues to ISO/GMP-compliant medical products, we help bring complex biomedical innovations safely and efficiently to clinical and commercial reality.

Biomaterials
Biomaterials

HCM Medical is expert in processing human and animal tissues into safe, high-quality materials for medical applications.

CMO
CMO

HCM Medical provides ISO- and GMP-compliant CMO services for production in ISO Class cleanrooms, from small-scale clinical batches to larger runs.

scCO2
scCO2

We use advanced processing technologies such as supercritical CO₂, aseptic handling, and freeze drying.

Transforming Biomaterials into
Advanced Medical Solutions

At HCM Medical, we apply an array of core technologies, including supercritical fluid extraction (SFE) and sterilization, freeze-drying, and collagen isolation and purification. Our commitment is to transform tissues of both human and animal origin into high-tech medical products crafted for a diverse spectrum of applications. In our pursuit of excellence, we excel in the purification of biomaterials such as collagen. Through the intricate processes of freeze drying, these materials are shaped into 2- and 3-dimensional constructs, opening new dimensions of possibilities for a range of medical applications.
/ Quality Support /

GMP-licensed to develop and produce clinical batches of IMPs.

MDR Registration

Expert support for efficient, compliant EU Medical Device Regulation registration.

/ Faq /

Everything you need to know about

01 - What quality standards does HCM Medical follow in manufacturing medical implants?

HCM Medical adheres to the highest applicable quality regulations, ensuring that every production process meets strict healthcare industry standards. We hold certifications including ISO 13485 for medical devices, a GMP licence for Investigational Medicinal Products, and recognitions from WVKL and NVWA.

We are certified with ISO 13485 for medical devices, possess a GMP licence for Investigational Medicinal Products, are recognized by WVKL as a tissue establishment, and hold NVWA recognition for manufacturing category 3-material medical devices.

Our distinction lies in our deep expertise in upscaling and validating production processes. From initial formulation through packaging and sterilization, we ensure quality and safety at every stage, making us a reliable partner from concept to final product.

We combine a passion for innovation with precise execution, bringing advanced knowledge and regulatory expertise to help evolve healthcare through high-quality, safe, and effective medical products.