• MEDICAL
    DEVICES

CREADIS > INDUSTRIES > LIFE SCIENCE > MEDICAL DEVICES

MEDICAL DEVICES

                                     

Regardless of what kind of medical devices you manufacture, DIS/CREADIS can help optimize production or develop your products to be competitive, reliable, and compliant.  

 

Reliable and optimized production that complies with the regulatory requirements of authorities and GMP is essential for any manufacturer of medical devices.

 

The innovation, digitization, and development of new products and categories in medical devices are moving faster than ever, and it can be a challenge to get untested technologies and fast time-to-market to align with wide-ranging regulation, high quality requirements, and sustainable products.

A WIDE RANGE OF SPECIALIST SKILLS

                                     

We believe that trust and peace of mind are crucial, and ensure we match your challenges with the right skills to see your project through. We have highly specialized engineers with many years of experience in the medical devices industry, particularly the development of specialist, test, and production equipment – mechanical, electronic, and digital – as well as validation and master plans.

 

We can also offer DIS/CREADIS consultants to work on-site, shoulder to shoulder with your team.

A WIDE RANGE OF SPECIALIST SKILLS

SERVICES WE OFFER

                                     

SERVICES WE OFFER
  • Product/solution innovation and concept development sessions
  • Regulatory, eg. ISO 13485, Risk assessment, FMEA, IEC 62304 SW
  • DOE’s & root cause analysis
  • Feasibility studies
  • Robust design and Six Sigma
  • Certifications, CE Marking & Documentation
  • Instructions and processes
  • Configuration of products and programming

 

Mechanics:

  • 3D modelling in CAD & 2D GPS
  • Interface analysis and tolerance stack analysis
  • FEM, FEA, CFD & digital twins

 

Hardware:

  • PCB Schematics
  • PCB Layout
  • Design control and verification
  • EMC analysis
  • Test specification and execution
  • Design Verification and validation
  • Documentation

 

Embedded software:

  • System architecture
  • Interface design
  • System specification
  • Test specification and execution
  • Design Verification and validation
  • Documentation

CASES

                                     

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