Medical Industry

Engineering & Quality Solutions

We support several medical companies in the areas of surgical devices & instruments, equipment diagnostics of all types (specialty, laboratory, sterilization, and safety), hospital furniture, patient repositioning systems, and orthopedic implants.

  • Product Design & Development per FDA, MDD & CMDR Regulations
  • Advanced Manufacturing & Process Engineering Support: CNC/CMM Programming, IQ, OQ & PQ
  • Quality Documentation & Internal Audits: FDA, ISO13485, FAI, Review UDI, CoC, CAPA & PPAP
  • Global Staffing Resources
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RGBSI is a global company, headquartered in Troy, Michigan USA, and has presence in: USA, Canada, Mexico, Germany, and India.

We provide services in the areas of engineering, manufacturing, process engineering, manufacturing, quality, staffing, and software development.

We have experience with medical regulations and standards: ISO 13485, FDA regulatory requirements for USA (21 CFR 807-820), medical device directive for Europe (MDD 93/42/EEC), and medical device regulations for Canada (SOR 98/282).

Engineering & Commodity Experiences

Our commodity experiences include: biomedical, electrical, electronics, mechanical, plastics, sheet metal, fabrications, castings, rubber, and glass for A-Z engineering including:

  • New Product Design & Development (NPD) in CATIA V5, UGNX, SolidWorks, CreO, Inventor & other CAD software.
  • Concept Design with Rendering
  • Patent Research, Competitor Product Research & Benchmarking
  • Reverse Engineering
  • Detail Design & Production Drawings
  • FEA & CFD Analysis
  • Technical Documentation & Product Animations

Advanced Manufacturing & Process Engineering

  • IP, OQ & PQ Documentation
  • CNC Programming for new products in MasterCAM, UGNX, CATIA V5 & other software
  • CNC Programming optimization for existing products
  • CMM Programming
  • Fixture Design & Development
  • Gage Design & Development

Engineering Software Expertise

CAD

CATIA V5/V6, Pro-E/CREO, Unigraphics/NX, AutoCAD, Inventor, SolidWorks, Solid Edge

CAM

SmartCAM, MasterCAM, CATIA V5, Unigraphics, Vericut, CAMEO

FEA/CFD

HyperMesh, ABAQUS, ADAMS, ANSYS, Nastran, LS-DYNA, OptiStruct, COSMOS, VisVSA, Moldflow, Fluent, Star-CCM+, ANSA, Fe-Safe

Software: Our proprietary PDM software helps manage engineering product data.

Quality Lifecycle Management (QLM) Software

Our enterprise-wide, web-based quality lifecycle management (QLM) software helps manage customer projects, audits, IQ, OQ, PQ, quality documents including non-compliances, CAPA, control plans, etc.

Advanced Quality Services

Our enterprise-wide, web-based quality lifecycle management (QLM) software helps manage customer projects, audits, IQ, OQ, PQ, quality documents including non-compliance, CAPA, control plans, etc.

Create, Review & Verify Quality Documentation:

  • First Article Inspection/CMM Inspection Reports
  • Part Marking & Traceability
  • Labeling as per UDI Requirements
  • Certificate of Compliance (COC)
  • Non-conformance management (CAPA
  • New emerging processes like PPAPs (like creating PFMEA, Control plans)
  • Related to FDA approvals
  • Internal Audits: FDA, ISO13485 and action items for continuous improvements
  • Supplier development
  • Complaints
  • Adverse Event Reports
  • Risk Management per ISO 14971
  • ANSI/ASQC M1-1996 for Calibration
  • ANSIASQ Z1.4-2008 for Sampling Procedures & Tables for Inspection by Attributes
  • ANSI/ASQC M1-1996: American National Standard for Calibration Systems
  • ANSIASQ Z1.4-2008: American National Standard Sampling Procedures & Tables for Inspection by Attributes

Staffing

  • We provide resources on contract, contract to hire, and direct.

Why RGBSI for Medical Engineering & Quality Expertise?

  • World class, state-of-the-art design and development facilities with the latest infrastructure and technology to drive innovation.
  • Proven expertise in medical engineering (end to end solutions from conception to manufacturing).
  • World class services in quality and quality software solutions to the medical industry.
  • Provide global support to customers and their suppliers.
  • Leverage our Global Technical Centers to lower operating expenses.

Need help with your next engineering project? Get in touch with us.
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