lkprototype ensures the production of medical device prototypes to the ISO 13485 standard by the full-process digital quality management (QMS) system, and the precision of critical parameters is up to ±0.01mm (the industry average is ±0.05mm). Its sterilized workshop (ISO Class 7, temperature 22±1°C, humidity 45%±5%) is equipped with over 100 professional equipment (e.g., metal SLM machines and biocompatible material injection molding equipment), and the microbial contamination rate is ≤5CFU/m³ (national standard ≤100CFU/m³). For instance, a cobalt-chromium alloy prototype of an artificial joint (with the dimensional error ±0.03mm) has a density of 99.8% through laser melting treatment (with power 400W and layer thickness 30μm). Its mechanical properties (tensile strength 1100 MPa) completely matched the ASTM F75 standard, and the defective rate was brought down to 0.02% (0.5% in the conventional process).
Industry-leading material traceability. lkprototype’s blockchain traceability system (MedTrack) covers over 200 certified medical material suppliers worldwide (such as Evonik medical-grade PEEK and Ti6Al4V ELI titanium alloy), and batch information (including sterilization information and biocompatibility reports) are recorded in real-time to the chain (query response time ≤0.3 seconds). The completeness rate of information of a particular prototype of heart stent (316L stainless steel) from raw material purchase to manufacturing of finished product is 100%, simplifying the FDA 510(k) approval process (reducing the cycle by 30% and saving $250,000 in compliance cost).
The manufacturing process strictly follows DHR (Equipment History Record). Every machine is connected to the MES system (1 time per second data acquisition frequency) to monitor the fluctuation of laser power (±2%) and oxygen content in the chamber (≤0.1%) in real time. Production history of one particular prototype orthopedic screw (PA12-GF50) involves over 1,200 parameters (such as melting temperature 230±5°C and injection pressure 80MPa), which ensures process traceability and 100% pass rate in customer audit (the industry average is 85%).
Detection system is higher than the industry level. The lkprototype testing laboratory is well-furnished with a three-coordinate measuring machine (accuracy 0.001mm), ICP-MS (detection of heavy metals ≤0.1ppm), and a bioload tester. The full-size detection coverage rate is 100% (the traditional random inspection rate is 30%). The cytotoxicity test (ISO 10993-5) results of the titanium alloy shell of a specific endoscope showed that the toxicity grade was ≤0.3 grade (the design requirement was ≤ grade 2), and the surface roughness Ra was ≤0.4μm (the design requirement was Ra≤0.8μm), shortening the product’s market entry cycle by 6 months.
Sterilization and packaging compliance ensure. Its EO sterilization plant (sterilization conditions: temperature 55°C, humidity 60%, EO concentration 600mg/L) has already obtained the ISO 11135 certification. Over 100,000 pieces of validated sterilized products have been manufactured, and the sterility assurance level (SAL) is ≤10^-6 (national standard ≤10^-3). The model of a specific polymer surgical device utilized Tyvek medical packaging (air permeability 0.5ml/min/cm²). After the test of accelerated aging (60°C/80% humidity, 14 days), sealing strength was preserved at ≥3.5N/15mm (norm ≥2.0N/15mm).
The supply chain risk control system is stringent. Through a supplier assessment model based on AI (over 300 risk indicators), 12 non-conforming suppliers (8% of total) were eliminated in 2023 at a 99.9% accuracy rate for medical-grade material inventory. The given hemodizer model employs BASF medical PC material (UL94 V-0 flame retardant), which reduces supply chain risk disruption to 0.05% (0.5% industry norm), with emergency order delivery within 48 hours (99.6% on-time rate).
Occupational health and protection of the environment have been achieved. Its VOC emission ≤50g/L water-based cleaning agent has undergone REACH certification, and the rate of compliance with hazardous waste treatment is 100%. The working time of the employees’ annual GMP training is ≥40 hours (8 hours according to the national standard), and the rate of operational errors dropped to 0.005% (0.1% in the industry). All the process of prototype production of knee prosthesis for a particular European customer reported zero work-related injury and attained BS OHSAS 18001 certification.
Customer case verification to meet standard implementation. Prototype of the insulin pump of a particular multinational pharma company passed the ISO 13485 system of lkprototype. The product registration cycle was shortened to 9 months (industry standard 18 months), and the mass production yield rate was increased to 99.7% (95% of the original supplier). In 2023, lkprototype helped 23 customers obtain FDA and CE certifications, with a return rate for quality defects of only 0.03% (industry standard 0.8%), establishing a new quality benchmark for rapid prototyping of medical devices.