3D resins compliancy and certification of medical devices

Key message: 3D resins can support compliance, but medical device certification applies to the finished device and the validated manufacturing workflow, not to the liquid raw material alone.

What determines compliancy in photopolymer 3D printing

3D resins compliancy with different FDA and ISO requirements for manufacturing biomedical devices (dental, orthodontics, otoplastics, prostheses, implants, etc.) depends on their tuning and customisation to the right printing and post-processing ecosystem, supported by well designed and validated biomedical manufacturing protocols and workflows.

Why device certification cannot rely on “raw material certifications”

Medical device certifications cannot rely on “raw material certifications”, because finished-part safety and performance are affected by multiple variables outside the raw material supplier’s control.

Typical variables that change outcomes

Equipment used: the printer and post-processing units, their quality and specifications.
Process settings: printing and post-processing parameters selected by the user.
Quality controls: instrumentation, protocols, validation and acceptance criteria.

As a result, even “compliant” resins can fail key safety/quality requirements for a given device class, for example the residual monomer content and related conversion-dependent risks.

What “designed and tuned” means in practice

3D resins need to be designed and tuned in accordance with appropriate printing and post-processing units, protocols and workflows (overall medical device manufacturing quality validation) to reach maximum biocompatibility and reproducibility.

How 3Dresyns can support medical device manufacturers

3Dresyns offers consulting services to help biomedical device manufacturers choose reliable printing and post-processing units, and to design and implement qualified protocols and workflows to manufacture validated biomedical devices that are compliant and certifiable with relevant medical device requirements (FDA and ISO, Class I, II, III, IV, etc.).

3Dresyns engineering programs

Learn more: About 3Dresyns certifications