your development and manufacturing partner for medical ......• moldflow / fe analysis • fmea •...
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Committed toDrug Delivery DeviceManufacturing
forteq Healthcare
Your Development and Manufacturing Partnerfor Medical & Drug Delivery Devices
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Where we bring added value to the customer
Full Support along the Product Creation Stream
Identify market needsIdentify trends
Anticipate needs arising in the market
Identify and define the users requirements
Technology developmentTechnology
integration
Development of innovative solutions
Develop technology platforms
Concept & DesignFeasibility
studies
Customization of technology
Concept design
Product design
DFMEA
Prototyping
Prototype tooling
Working samples
Design verification
Pilot production
PFMEA
Pilot equipment
Samples for clinical trials
Process verification
Industrialization
Validation master plan
Equipment qualification
Production & quality documentation for regulatory submission
Mass productionDevice
manufacturing
Quality control
Logistics
GMP compliant
Swissmedic / Drug Handling
Final packaging
ManufacturingDevelopment
Product examples
Dose Counter for Aerosol InhalerDry Powder Inhaler
Implant Inserter
• Convenience, safety & robustness packed into innovative device solutions
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R&D support – Application development
• Design for manufacturing / Design for assembly
• Feasibility studies & Risk assessments
• Root cause analysis
• Moldflow / FE analysis
• FMEA
• Material evaluation
• Gearwheel calculations
• Testing, Design review, Design validation
• Design History File
• Support for CE marking
Product development : Process developmentHC Teaser 4
Tool Shops – Mould manufacturing in Asia & EU
High precision tooling : Injection moulding
• forteq owned and Swiss managed tool shop in China• Short lead times • Competitive cost-performance ratio• Swiss quality / Swiss on-site Engineer & Tool Shop Manager
• Use of experienced local EU toolmakers
• Swiss tool maintenance
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Production Engineering
Validated processes : Qualified equipmentHC Teaser 6
• Mould tool design & process Engineers• Tool layout, specifications/URS , tool qualification, process set-up
and validation, windows studies, etc.• Automation & process Engineers
• Machine layout, specifications/URS, equipment qualification, process development and validation, etc.
• Senior Project Managers• Customer interface, budgets, resources, planning, etc.
Our facilities – Clean room manufacturing
High precision tooling : Injection mouldingHC Teaser 7
Our facilities – Clean room manufacturing
Assembly : Printing : Welding : PackagingHC Teaser 8
forteq Healthcare in a nutshell
Core competence Development & manufacturing of medical anddrug delivery devices
Application focus Inhalation, Injection, Reconstitution & Extraction
Swiss precision This location enables access to typical Swiss quality services
Staff 90 employees / 15 development & process engineers
QualificationsGMP compliant / Feb. 2017 renewal of license to handle primary drug containers / ISO 9001 / ISO 13485 / clean rooms ISO14644, classes 7 & 8
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Your commercial contact persons
Headquarters & Technical Centre:forteq Nidau AGIpsachstrasse 14CH-2560 NidauSwitzerlandwww.forteq-group.com
Beat WasserManaging Director HealthcarePhone +41 32 332 73 23Mobile +41 79 234 34 53 Email [email protected]
Leo LawlessBusiness Development ManagerPhone +353 90 663 59 64Mobile +353 87 206 64 38Email [email protected]
ISO 9001:2008EN ISO 13485:2012GMP compliantClean rooms ISO14644, Class 7 & Class 8
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