Additive Manufacturing

Laser powder-bed fusion technology for direct metal printing of medical implants, instruments and components

Cretex Medical | rms was one of the first medical device manufacturers to offer validated LPBF products. With over a decade of experience and 1,000,000 sellable AM parts, our investment in industry-leading additive manufacturing technology allows us to design and produce components and devices with amazing complexity.

With over 30 metal AM systems staffed by highly trained technicians and supported by a team of quality and manufacturing engineers, our facilities can bring your design from prototype through production.

Capabilities

• Layer Thickness:
  • 30 and 60 µm typical (no max)
• Build Envelope Capacity: 10.82 x 10.82 x 16.53 in (275 x 275 x 420 mm)
• Repeatability: x=20 µm, y=20 µm, z=20 µm
• Minimum Feature Size: 100 µm
• Typical Accuracy: ± 0.1-0.2% with ± 50 µm minimum
• Argon atmosphere: Extremely low O2 present in the chamber during build (25 ppm) produces parts free of alpha case and allows for extensive powder reuse without compromising part quality
• Capable of several different trabecular and functionally porous structures

Expertise in current trends and approaches of gaining FDA clearance of AM devices

The FDA has provided formal guidance on items that need to be considered and included when submitting new additively manufactured devices for regulatory clearance. If AM products are submitted incorrectly or insufficiently, long delays and other pitfalls are likely. The rms additive engineering teams experience, in combination with several Master File Reports with the FDA, simplify the submission of AM products so we can help our customers get their product to market faster.

The rms AM team implements the latest industry best practices, follows expert guidance, and holds multiple certifications. Our certified processes reduce risk and accelerate regulatory approvals so we can deliver safe, compliant, and reproducible products.

Partnering with you to increase efficiency and drive down costs

While additive manufacturing is not appropriate for all design features, AM does offer product designers never-before-seen design freedom. We look at the production process from start to finish and implement designs that streamline secondary processes, while using the best manufacturing techniques to achieve high quality and repeatability.

Geometric dimensioning and tolerancing (GD&T) of complex AM designs present additional challenges rarely encountered with conventional manufacturing. rms utilizes state of the art inspection and testing techniques like industrial CT scanning to ensure our products meet customer requirements.

Simplifying the supply chain through single-source production

We offer a wide array of secondary processes in-house, as well as additional services through the Cretex Medical family of companies and our network of trusted supply partners.

Vertical integration shortens supply chains and drives faster production, communication and decision-making.

Capabilities

• Precision machining, turning and milling
• Automated residual powder removal
• Wire EDM
• Automated blasting
• Ultrasonic cleaning
• Vapor degreasing
• Nitric passivation
• Laser marking
• Color anodizing
• Automated polishing
• Assembly
• Laser welding
• Heat treatment (via validated, approved suppliers)
  • Hot isostatic processing (HIP)
  • Vacuum annealing
  • Vacuum stress relief
  • Age hardening