Machinery
directive
Machinery
directive
Robust design for compliant
and safe machinery
We help you demonstrate that your equipment is compliant with the EU directive.
Technical file of the equipment helps you to review your design
and build safe machinery, applying the CE mark.
Our capabilities
- Design development and review for safety
- Safety essential requirements review
- 2006/42/EC directive
- Technical file
- Risk analysis of the machine (ISO 12100)
- ISO 60204 compliance
- PL Calculation (ISO 13849)
- Software safety validation
- User and maintenance manual using InDesign
- Translations in Italian, English, Spanish and French
- Integration with process validation
- Integration with customer quality management system (QMS)
Experience
- Machines for medical processes
- Packaging machines
- Pharmaceutical automations
- Cosmetics automations
- Food automations
- Automotive
- Custom automations
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Medical
devices
Medical
devices
Robust design
for compliant products
We help you demonstrate that your medical device
is compliant with MDR EU/2017/745
and is able to get European market access.
Technical documentation serves to prove that a medical device meets
the general safety and performance requirements and should be prepared in a clear, organised, readily searchable and unambiguous manner.
Our capabilities
- MDR EU/2017/745 (and previous directives)
- ISO 13485:2016
- Support in medical device technical documentation submission to Notified Bodies
- Benefit-risk analysis and risk management (ISO 14971)
- General Safety and Performance
- Requirements review
- Sample size procedure for product V&V testing
- Product labelling (ISO 15223)
- Design for manufacturing approach
- QMS procedures
- Regulatory Affairs consulting
- FDA remediation
- Integration with customer quality
- management system (QMS)
Experience
- Cardio polmunary medical devices
- Disposables and cannulae for circulatory support
- Extracorporeal Perfusion systems for hemodialysis
- Dental surgical equipment (piezoelectric devices, LED curing lamps, ultrasonic devices)
- Absorbable and non-absorbable sutures for ophtalmic, dental, plastic surgery and cardiac applications
- Thoracic catheters and wound drainage
- Disposables for anesthesia and rianimation
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Process
validation
Process
validation
Know your process
without making assumptions
We help you demonstrate your process is consistently delivering quality products.
Validation is a must to gain statistical control on your process, reduce the scraps and meet the market and regulatory requirements.
Our capabilities
- User requirements specification (URS)
- Technical requirements specification (TRS)
- Validation master plan
- Process mapping
- Process FMEA
- Equipment qualification
- Support to FAT/SAT
- Installation qualification (IQ)
- Operational qualification (OQ)
- Performance qualification (PQ)
- Process validation procedure
- Statistical sampling procedure
- Measurement system analysis (MSA)
- Test method validation (TMV)
- Process Development
- Design of experiment (DoE)
- Six sigma
- Lean Manufacturing
- Software validation
- Design transfer and design control
- Packaging validation (ISO 11607)
- Support to clean room validation methods (ISO 14644)
- Support to sterilization validation methods (ISO 11135 - ISO 11137 - ISO 17665)
- Integration with customer quality management system (QMS)
Experience
- Injection moulding process validation
- Extrusion process validation
- Lean manufacturing implementation and training
- Packaging validation (ISO 11607)
- Leak test validation
- Dip moulding validation
- US welding validation
- Manual assembly validation
- UV gluing validation
- Hot melt and other dispensers validation
- Ovens and thermal treatments validation
- Cutting machines validation
- Custom assembly machine validation
- Thermoforming and filling machines validation
- Gage R&R and Attribute Agreement Analysis for Test Method Validation
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Software
validation
Software
validation
Be sure
your software works
as intended
We help you demonstrate your software is compliant with specifications and regulations.
Validation is a must to assure your software works as expected, compliantly and safely.
Our capabilities
- GAMP 5 approach
- Regulatory Compliance (IEC 62304)
- Software URS
- Software specifications
- Software risk analysis
- Software verification and validation
- FDA Title 21 CFR par t 11 compliance
- GxP approach
- COTS software validation
- Spreadsheet macros validation
- Custom software validation
- Traceability matrix of the requirements
- Safety features testing
- Integration with customer quality management system (QMS)
Experience
- ERP validation (Priority, Mago, Business Central, BPCS...)
- Asset Management Software (Scops.ai, EAM, …)
- Minitab software validation
- Validation of software for manufacturing processes
- Labelling software (NiceLabel)
- Minitab software validation
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Physical
testing
Physical
testing
Characterize
your piece to make
the right decisions
We provide you accurate and precise measurements and relative data analysis. We offer the possibility to work in synergy with our experts, sharing ideas, instruments and laboratory spaces.
Physical measurements lead customers to a better understanding of their products/processes. GB Soluzioni Laboratory has more than 50 calibrated instruments used to independently and rigorously verify, measure and test, enabling customers to obtain a product that is aligned with expectations and applicable requirements.
Dimensional measurement
- Automated process suitable for large amount of measurements
- Resolution down to 0,1 μm
- Optical measurement in XYZ
- Touch probe in XYZ
Torque and force
- Primary packaging test according to ISO 1160, EN 868-5
- Tensile strenght test
- Resolution down to 0,01N
- Maximum load force: 1000N
- Maximum torque: 6 N.m
- Speed up to 500 mm/min
- Force/torque diagram
Mass and weight
- Resolution down to 0,001 g
- Full scale up to 410 g
Small-bore connectors testing ISO 80369
- Dimensional testing
- Fluid leakage testing by pressure decay
- Sub-atmospheric pressure air leakage
- Stress cracking
- Resistance to separation from axial load
- Resistance to separation from unscrewing
- Resistance to overriding
- Non-interconnectable dimensional analysis via CAD
- Test method validation
- Automated assembly to reference connectors with programmable torque tester
Flow and leak
- Resolution down to 1 Pa
- Resolution down to 1 cm³/h
- Full scale from - 0,9 to 6 bar
- Full scale up to 50 cm³/ min
- Leak and flow test assessing
- Pressure and flow graph-chart
- Verification and certification of pressure measurements
Experience
- Tyvek, paper, paper/film sealed pouches tested
- Medical devices moulded components measured using OGP (using Zone 3 and previous software versions)
- Twist test on moulded parts
- Torque test
- Cyclic tensile strength test
- Tensile test on connections and pump segments for kidney treatments
- Test method development and Working Instruction drafting
- Test method validation
- Full integration with Healthcare consultancies for statistical data analysis and rapid prototyping for custom fixtures
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Rapid
prototyping
Rapid
prototyping
Professional
carbon fiber 3D printing
(powered by Markforged)
We build resistant design rapidly and cost effectively.
Additive manufacturing technologies is a cost-effective way
to develop projects, data visualization and rapid prototyping.
Our capabilities
- 3D printing using ONYX (micro carbon fiber filled nylon with twice the strength and stiffness of standard printing plastics) and PLA
- Layer thickness between 50 μm and 200 μm
- Build volume: 330 x 270 x 200 mm
- SolidWorks 2D and 3D modelling
- Drawing review
- Concept development
Experience
- Hundreds of fixtures printed for components positioning under optical machine in biomedical industry
- Custom pieces-holders and fixtures for testing
- Rapid prototyping for automotive industry
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Statistical analysis
and training
Statistical analysis
and training
To understand the World,
learn to understand Statistics
We help you
use statistical methods in manufacturing
process improvement.
Statistical concepts and methods are developed and applied in industries for monitoring the quality of products, planning effective and efficient designs to improve standards, testing and analyzing the quality of items produced, and accepting (rejecting) conforming (nonconforming) units produced.
Our capabilities
- Basic Statistics (descriptive statistics, mean, standard deviation, variance, mode, median...)
- Hypotesis Tests
- Graphical Analysis
- Capability Analysis (Cp, Cpk, Pp, Ppk)
- Regression Design of Experiment (DoE)
- Control Charts
- Normality Test
- Montecarlo Simulation
- Tolerance Intervals definition
- Analysis of Variance (ANOVA)
- Minitab Statistical Sampling
- Procedure ARIMA Models
Experience
- 40 hrs statistical training accomplished involving engineering, R&D and quality departments of mayor biomedical companies
- Real study cases analyzed, according to customer’s needs
- Full integration with Healthcare consultancies and Laboratory tests