Biocompatible material selection and certification
Regulatory documentation and traceability requirements
Sterile packaging and handling protocols
Prototype testing before clinical trials and submissions
Small batch production for pilot studies and validation
Medical-grade plastics, stainless steel, and titanium suitable for non-implant medical device prototypes.
Material certifications, inspection reports, and manufacturing documentation for regulatory submissions.
Smooth transition from prototype to small batch production for clinical trials and market validation.
50 units for FDA 510(k) submission testing
"The material documentation and quality were exactly what we needed for our regulatory submission. Professional and responsive team."
Tell us about your project and we'll provide recommendations, pricing, and realistic lead times.