bmed short intro
DESCRIPTION
Balda MedicalTRANSCRIPT
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Balda Solutions
Medical Segment
Company Introduction
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Balda Medical GmbH & Co.
Business Unit of Balda Solutions est. 1908
Locations:
Technology Park in Bad Oeynhausen, Germany
China, Malaysia and the USA
Markets: Pharma, Diagnostics and Medical technology
Business activities: Customer-based development, Industrialization
and Production of plastic parts and sub-assembly units
Other Balda products : Electronic Accessory Competences (EMS) :
Infocom, Automotive, Touchscreen, mobile phone,
cameras ,etc
Equipment: Hundreds of precision injection molding machines, fully
automatic assembly and surface treatments (finishing & processing)
Balda Solutions has over 7,000 employees worldwide
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Product expertise
Product development
Product concept
Design / form und function
Fully integrated product
development
Products suitable for production
Product know how
Mechanics / Kinematics
Dosing
Packaging
Special functions
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Industrialization
Means of production
Sourcing strategies
Tools
Printing & Assembly
In-house maintenance &
repair
Production environment
Clean room
Controlled area
Most advanced
infrastructure
Process development
Process competence
Process stability
Process quality
Integration of
secondary processes
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Production
Injection molding 1K, 2K Multi-cavity Thin wall Inserts (Metal, Glass)
Decorating Stamping Painting Laser marking
Assembling Joining / connecting
technologies Assembly concepts
Packaging Individual sorting of
devices / components Handling of variants Logistics concepts
IML / IMD Injection embossing (injection
compression molding)
Printing
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IMD and 3D-IMFTechnologically and economically on the highest level
IMD (Inmold Decoration) Possibility of photo-realistic presentations For wide surfaces, transparent or slightly bent components Better surface characteristics (structure, hardness, transparency, high gloss) Decoration and production of the part in one step
3D-IMF (Three Dimensional Inmold Foiling) Greatest choice of graphics and colors, including metal, leather, wood and carbon optics as well
as chrome and special effects Back injection molding of decorated, 3D-preformed foils Extended 3D-ability compared to the IMD technology Multi-level process Decoration and production of the part in one step
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Quality
Ways to quality Specifications Quality planning Qualification & Validation
Motivated Team Competence and Trainings Personal responsibility Identification of individual accountability
On a par Document quality “Limiting sample” system CAQ System (Guardus)
Measurement technology Most advanced measurement equipment Documentation of results Externally as a service
Certificates Competence in market
authorization
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Certifications
DIN EN ISO 9001
DIN EN ISO 13485
DIN EN ISO 14001
DIN EN ISO 14971
FDA Registered
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Safety through partnership
Attitude / Approach
Long-term partnership
Commitment
Transparency
Ability to accept constructive
criticism / comments to improve
products
System
Improvement management
Product management
Risk management
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Risk managementAvoid the unsteerable, control the unavoidable
Design Controls
Risk analysis
Design Reviews
Change Controls
Design History File
Process Controls
Risk-related process
validation
Supplier management
Documentation of
production
System Controls
DIN EN ISO 13485
DIN EN ISO 14971
Risk management for
medical devices
Methodological
competence
back
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Cost-effectiveness
Investment
Compatibility of the
equipment
Standardization
External sourcing
Article costs
Reviews
Competence in
automation
Total cost of ownership
Time to market
Competence of staff
Stable processes /
positive planning
Clear decision-making
proposals for customers
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Measurement technology
Our service
Measurement technology consulting
Analysis and evaluation of components and
systems
Tactile and optical measurement
Digitalization / Laser scan
Computer tomography
Your requirements
First sample test reports
Analysis of process capability
Measuring system analysis
Color-coded deviation report
Special measurements and analysis
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Aim: increased medical compliance Clear style (forms and colors) Ergonomic design Development of variants Cooperation with external partners
Designing, Styling & ShapingCreate additional value by designing
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Examples of productsHandheld Devices
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Examples of productsDisposables
Pipettes Sleeves Tubes Glass connectors
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Examples of productsPackaging and Dosing
Pills, liquids, powder, film-coated tablets
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Examples of productsFunctional sub-assembly units
Mechanics, Kinematics, Counter, Fluidics, Electronics
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Thank you for your time
Additional questions please contact :
Hector A [email protected] : (408)761-6276
Hector A MazaNational Sales Manager USA
Balda | Solutions USA
2803 Slater Road, Suite 207 |Morrisville, NC 27560Web: http://www.Balda-USA.com
Ph: +1 (919) 459-1660 x229 | Fax: 459-1661 Email: [email protected]
Mobile : +1(408)761-6276