Seamless Biomaterial Forming as Part of Our End-to-End Solutions
LSO provides precision biomaterial forming to ensure structural integrity, biocompatibility, and regulatory compliance. As part of our end-to-end solutions, we help medical device manufacturers streamline development, from material shaping to market-ready implants.
What is Biomaterial Forming?
Biomaterial forming involves shaping, molding, and processing synthetic and natural biomaterials into functional medical implants and components.
Custom shaping: Precision forming for complex implant geometries.
Material compatibility: Processing biocompatible polymers, ceramics, and metals.
Regulatory compliance: Meeting stringent FDA and ISO standards for safety and efficacy.
Who Needs Biomaterial Forming?
Medical device OEMs developing implantable solutions.
Orthopedic and dental manufacturers requiring precise material shaping.
Material Selection & Preparation: Choosing the appropriate biomaterial based on mechanical properties, biocompatibility, and regulatory requirements.
Precision Molding & Forming: Utilizing advanced forming technologies, including injection molding, compression molding, and extrusion.
Thermal & Chemical Processing: Enhancing material properties through curing, sintering, or surface treatments.
Quality Control & Validation: Conducting rigorous dimensional, mechanical, and biocompatibility testing to ensure regulatory compliance.
What standards apply?
ISO 13485 – Quality management system for medical devices.
FDA 21 CFR Part 820 – U.S. FDA quality system regulation.
Why LSO?
As an FDA-registered and ISO 13485-certified contract manufacturing organization, Life Science Outsourcing (LSO) offers assembly, packaging, sterilization, and specialized capabilities in diagnostics packaging and design. Our unique business model combines comprehensive in-house services and extensive regulatory expertise, allowing us to provide the agility and flexibility needed to expedite market launches while standardizing the supply chain and minimizing risks.