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.