Medical Device Solutions
Medical Device Solutions Galway Ireland is a European based consultancy firm specializing in Product Development, Design for Six Sigma, and Regulatory Compliance within the Medical Device Sector. They focus on helping businesses develop and commercialize medical devices for worldwide release, providing expertise in Product Development, Product Qualification, Six Sigma, Lean Six Sigma, Design for Six Sigma, Validations, Reliability Engineering, Regulatory Compliance, Technology Transfer, and Training.
Industries
Nr. of Employees
small (1-50)
Medical Device Solutions
Galway, Galway, Ireland, Europe
Services
Six Sigma
Consulting on Six Sigma methods to reduce variation and improve process performance within medical device operations.
Product Development
Support for end-to-end medical device product development including requirements capture, design, prototyping and launch readiness.
Design for Six Sigma
Implementation of DFSS methodologies and tools to create robust designs that meet customer requirements.
Lean Six Sigma
Lean Six Sigma approaches to streamline processes and eliminate waste in product development and manufacturing workflows.
Validations
Validation planning and execution services including protocol development and validation best-practices.
Reliability Engineering
Reliability engineering services covering failure data analysis, accelerated testing and reliability prediction to improve product life.
Six Sigma
Consulting on Six Sigma methods to reduce variation and improve process performance within medical device operations.
Product Development
Support for end-to-end medical device product development including requirements capture, design, prototyping and launch readiness.
Design for Six Sigma
Implementation of DFSS methodologies and tools to create robust designs that meet customer requirements.
Lean Six Sigma
Lean Six Sigma approaches to streamline processes and eliminate waste in product development and manufacturing workflows.
Validations
Validation planning and execution services including protocol development and validation best-practices.
Reliability Engineering
Reliability engineering services covering failure data analysis, accelerated testing and reliability prediction to improve product life.
Expertise Areas
- Product development for medical devices
- Design for Six Sigma (DFSS) implementation
- Reliability engineering and life-data analysis
- Regulatory compliance and medical device quality systems
Key Technologies
- Design for Six Sigma (CDOV)
- Design of Experiments (DOE)
- Failure Mode and Effects Analysis (FMEA)
- Fault Tree Analysis (FTA)