Medical Device Parts Manufacturing Service

Use ISO 10993-1 or USP Class VI certified materials such as PEEK, PTFE, or medical-grade stainless steel (316L). Avoid additives, coatings, or plasticizers that may leach. Validate certificates of analysis (CoA) from each batch for implant or patient-contact components.

Eliminate internal corners ≤0.5 mm radius to allow full sterilization. Avoid undercuts and blind holes that trap contaminants. Surfaces must meet Ra ≤ 0.8 µm for hand-contact areas or CIP/SIP zones. Use full radiusing and slope angles ≥3° for fluid runoff.

Use ISO 286 IT7–IT9 for fit-critical parts and ISO 1101 GD&T for datum control. Maintain coaxiality and flatness ≤0.02 mm for interfaces with seals, connectors, or instruments. Incorporate datum slots or self-aligning bosses for consistent part positioning during assembly.

Prioritize snap-fit joints, ultrasonic welding, or laser welding over threaded fasteners to maintain seal integrity and reduce particle generation. For critical fastening zones, use torque-limited fasteners and apply color-coded indicators for visual confirmation of closure integrity.

Validate designs with FEA under cyclic load conditions per ASTM F2077. For reusable parts, ensure ≥1 million cycles at 80% nominal load. Include safety factor ≥2 for surgical or handheld components. Use radiused transitions and avoid abrupt cross-section changes.

Ensure material and adhesive compatibility with EO, autoclave (134°C, 2 bar), gamma (25–50 kGy), or plasma sterilization. For multi-use devices, validate dimensional stability and color retention over ≥50 sterilization cycles. Avoid warpage-prone thermoplastics without fillers.

Separate conductive paths and patient-touchable surfaces using double insulation or shielding. Maintain creepage and clearance per IEC 60601-1 (e.g., ≥2.5 mm for 250 V). Isolate power and signal routes using grounded shields or PCB routing techniques for EMC.

Embed GS1- or HIBCC-format Unique Device Identifier (UDI) via laser mark (depth ≥0.1 mm) or 2D Data Matrix code. Position UDI in visible, non-wear zones. Ensure markings survive sterilization and abrasion testing (ASTM D4060 Taber Test ≥500 cycles, <0.2 mm loss).

Conduct design FMEA per ISO 14971. Address pinch hazards, leak paths, electrical overcurrent, and user misassembly. Design tamper-proof features and implement mechanical stops or visual cues to prevent incorrect orientation or operation. Validate safety margins in redundant load paths.

Align design with FDA CFR 21 Part 820 and EU MDR 2017/745. Prepare Design History File (DHF), Device Master Record (DMR), and Risk Management File (RMF). Maintain complete traceability across all components, inspection reports, and change control documentation.

Source materials that meet ISO 10993 or USP Class VI. Use 316L, titanium grade 2 or 5, PEEK, PPSU, or LSR with batch-level Certificates of Analysis. Ensure lot segregation and traceability throughout the value chain with material ID retention.

Achieve dimensional tolerances ≤±0.01 mm on features like implant interfaces, housing seals, and mating slots. Apply fine finishing (Ra ≤0.2 μm) for optical or surgical instrument surfaces. Validate tolerances with calibrated CMM using traceable metrology standards (ISO 17025).

Use ISO Class 7 or better environments for final rinsing, drying, and packaging. Maintain particle counts, temperature (20–22 °C), and humidity (45–55%). Restrict operations involving open parts to clean zones and document environmental monitoring per ISO 14644.

Avoid adhesive joints where sterilization is required. Use ultrasonic, laser, or thermal bonding for enclosure integrity. For torque-sensitive components, define torque specs to ISO 6789 and verify with calibrated tools. Ensure error-proofing in assembly using poka-yoke fixtures.

Specify electropolishing, vapor smoothing, or bead blasting under validated conditions to achieve uniform finish and eliminate burrs. For implantable or critical-use parts, ensure burr-free edges and particle shedding ≤0.1 mg per component post-cleaning (ISO 16232 or USP 788).

Design parts to withstand EO, steam autoclave (134°C for 5 min), gamma (25–50 kGy), or hydrogen peroxide sterilization. Avoid sharp internal corners and micro-channels that trap fluid. Validate dimensional stability post-sterilization with tolerance rechecking and visual inspection.

Apply Unique Device Identifier (UDI) via laser marking or micro-dot engraving (≥0.2 mm height, ECC200 DataMatrix). Store batch info digitally and link with Device History Record (DHR). Ensure markings are legible after 50+ sterilization cycles (abrasion and chemical exposure validated).

Implement 100% in-process inspection for critical-to-function dimensions. Use SPC with Cp/Cpk ≥1.33 and retain digital records for 10 years. Document with PPAP (Level 3), FAI, and full DMR (Device Master Record) per ISO 13485 section 4.2.4 and FDA 21 CFR 820.

Use medical-grade double blister packaging, Tyvek sealing, or pouching with ISO 11607-compliant materials. Validate drop resistance (≥1.2 m, 10 cycles), sterility barrier, and labeling legibility post-transport. Include IFU, lot ID, and expiration labeling per MDR/FDA requirements.

Ensure all manufacturing steps comply with ISO 13485:2016, FDA QSR 21 CFR Part 820, and EU MDR 2017/745. Maintain complete DHR, Risk Management File (per ISO 14971), and CAPA traceability. Prepare for Notified Body audits and FDA inspections with internal mock audits.