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Anecto's ISO 17025 accredited test facility provides world class support to product developers, designers and manufacturers. The state of the art laboratory is supported by technologists and engineers who also design and manufacture specialist products and support customer's warranty programmes.With over 12 years experience as a company providing Product and Packaging Testing, Consultancy, Support, Bespoke Test Equipment and Protocol Development to the Medical Device Industry Anecto understands and responds to those challenges.Anecto have a totally up to date knowledge of, understanding of and adherence to the pertinent regulations and standards stipulated by the FDA, the European Medical Device Directive, ISO 11607. We also understand that our clients successful compliance may require a combination of these and other relevant regulation depending on where in the world the product is to be distributed
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Today, over 75% of the Global Top Twenty Medical Device Companies use our services.
Find out why...
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
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Today, over 70% of the Global Top Twenty Medical Device Companies use our services.
About AnectoAnecto was established in 1994 to supply development, engineering and test support services to the ‘High Tech’ multi-national sector. Since that time it has developed into a leading ISO 17025 Accredited Testing Laboratory with a range of end to end services specifically developed for the Medical Device, Equipment and Pharmaceutical sectors.
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
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About AnectoCustomers in our major market sectors of Life Sciences, Medical Device, Pharmaceuticals, Food and Beverage, Electronics, IT and Automotive Electronics come mainly from Europe and the USA but also from many other markets including Japan, Brazil and Asia Pacific.
We work with a number of worldwide partners to provide the very best in products, services and equipment in the test arena.
Development of services is underpinned by international standards both for test procedures and company quality systems.
Our Services include:
• Product Reliability & Validation Testing • Packaging and Transportation Testing• Custom Designed Test Equipment• Consulting and Engineering Services
Contact us to discuss your particular needs.
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
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ISO 11607-1ISO 11607-1 specifies the requirements for materials and test methods, pre-formed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
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www.anecto.com
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ISO 11607-1Our services in this area include:
Under the auspices of our ISO 17025 accreditation.
• Protocol and Test Plan generation• Sampling Programs• Transportation and Distribution Testing• Accelerated and Real Time Aging• Integrity Testing: - Bubble Leak - Tensile /Peel - Dye Penetration - Vacuum Decay - Burst Test - Microbial Challenge• Final Reports
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
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ISO 11607-2:ISO 11607-2 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include the forming, sealing, & assembly of pre-formed sterile barrier systems, the sterile barrier systems themselves & the packaging systems.
Our services in this area include: • Consultancy - Process development - IQ – OQ – PQ• Test Plans and Protocols• Sampling • Validation Testing• Technical and Regulatory Files• Comparative performance studies• Packaging system analysis
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
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Trusted Test Experts
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ISO 11607-2
Typical Test Flow
TO TestReport
IQ OQ PQProduction Packages
DistributionSimulation
Package Integrity Test
PhysicalStrength Test
Package Integrity Test
PhysicalStrength Test
Package Integrity Test
PhysicalStrength Test
Package Integrity Test
PhysicalStrength Test
Package Integrity Test
PhysicalStrength Test
Package Integrity Test
PhysicalStrength Test
TO Base Line Testing
Accelerated Aging Testing
2 Year Accelerated Aging
3 Year Accelerated Aging
2 Year Accelerated Aging Report
3 Year Accelerated Aging Report
TO TestReport
Real TimeAging Testing
2 Year Real TimeAging
3 Year Real TimeAging
2 Year Real Time Aging Report
3 Year Real Time Aging Report
Sterilisation
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
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Trusted Test Experts
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Package & Transportation TestingPackaging in the Medical Device, Equipment and Pharmaceutical industries is about much more than aesthetics. It is about regulation, market share, reputation & profitability. Our Consultancy & Test services ensure that our clients address all of these issues in the best possible fashion.
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
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Trusted Test Experts
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Package & Transportation Testing
• Protocol and Test Plan Generation
• Sampling Plans• Fragility Testing• Comparative Performance
Testing• Shippers and Packaging
Testing to ASTM, ISTA, ISO Standards.
• Conditioning, - Temperature - Humidity• Mechanical - Drop - Compression/
Stack Height - Vibration - Incline/Impact - Edge Crush
• COBB• Grammage• Cold Chain• Altitude• Sterile Package
Integrity ISO 11607• Aging - Accelerated - Real-time• Bubble Leak• Burst• Seal Strength• Dye Penetration• Bubble Leak
under Vacuum• Microbial Challenge• Dangerous Goods• Final Reports
Under the auspices of our ISO 17025 accreditation.
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
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Trusted Test Experts
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Test EquipmentFinding the right Test equipment in the Medical Device Industry can be a real challenge.
It can be very difficult to find ‘off the shelf’ equipment that meets all of your criteria. At Anecto we understand these problems and have utilised our extensive test knowledge to solve them. We build a wide range of laboratory and in-line test equipment to suit our customers’ exact needs. This means that we may well have just the equipment you are looking for or we can build it to suit your particular requirements and to deliver to the necessary international standards.
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
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Trusted Test Experts
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Test Equipment
Equipment includes:
• Electronic systems• Mechatronic systems• Fluid Dynamic systems• Medical Equipment Test Systems• Medical Device Test Systems• Electronic measurement systems
Example machines include:
• Bubble leak testers• Vacuum testers• Burst testers• Flow & micro-flow testers
Ask us about our capabilities and talk to our customer base.
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
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Trusted Test Experts
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Consulting ServicesBrilliant ideas and market opportunities often fail to reach commercial realisation in a timely fashion through a lack of requisite knowledge, time or other resources in the essential non-core processes.
Anecto’s multidisciplinary team of Mechanical, Electronic, Software, Process and Packaging engineers coupled with our Quality, Regulatory, Design and Reliability consultants are available to take ownership of these non-core processes and enable our clients to concentrate on their core activities.
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
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Trusted Test Experts
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Consulting ServicesOur team’s knowledge is derived from years of experience of designing, consulting, testing and project management for the electronics and medical device sectors.
Services in this area include:• A range of industry training courses
both standard and custom.• Packaging Reliabilty Analysis & Design• Test Process Analysis & Design• Remedial work on existing packaging• Remediation & Legacy Product audits• Design Verification Testing• Product & Process Validation• In-depth research, analysis & prompt evaluations
of test and inspection equipment needs • Customised Test Equipment• Packaging Design• Protocol Generation• Technical File Preparation • Regulatory preparation & submission• CE marking• After market servicesContact us to discuss your particular needs.
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
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Trusted Test Experts
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Product TestingProduct testing takes many forms and at Anecto, we are involved in the majority of them. From physical performance to accelerated life testing. From environmental to safety. From design to end of functional life.
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
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Trusted Test Experts
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Product Testing
Our services in this area include:
• Mechanical• Electronic• Performance• Functional• HALT (Highly Accelerated Life-Testing)• Safety• EMC• Ingress Testing• Chemical/Corrosion/Salt Spray• Medical Device
Product Testing• Medical Electronics• Testing of Catheter
Devices• Testing of Implantable
Vascular Devices
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
Print \ Email \ Minimise
Trusted Test Experts
Home
Today, over 70% of the Global Top Twenty Medical Device Companies use our services.
Product Testing
Medical Device Product Testing:
• Design Phase• Design Validation & Verification • Simulated Use• Failure Analysis
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
Print \ Email \ Minimise
Trusted Test Experts
Home
Today, over 70% of the Global Top Twenty Medical Device Companies use our services.
Product Testing
Testing of Catheter Devices:
• Fluid Dynamics (Flow, Burst, Leak)• Mechanical Performance [Tensile, Kink, Torque)• Dynamic Performance (Push, Track, Cross)• Balloon Compliance & Inflation/Deflation• Radiopacity
Testing of Implantable Vascular Devices:
• Stent & Stent Graft Fatigue• Radial Strength• Bending (Crimped &
Deployed)• Stent Detachment• Radiopacity
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
Print \ Email \ Minimise
Trusted Test Experts
Home
Today, over 70% of the Global Top Twenty Medical Device Companies use our services.
Product Testing
Medical Electronics
• Reliability Testing• HALT/HASS (Highly Accelerated Life Testing)• Safety• EMC• CE Marking• Medical Equipment Test, Repair & Warranty Services
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
Print \ Email \ Minimise
Trusted Test Experts
Home
Product Development Flow ChartAbout Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
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Trusted Test Experts
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Customer Needs
Design
Prototypes
Design Correction
ISO 11607 Testing SterileIntegrity Validation
Design Verification Test
FailuresYes
Test
Design Correction
Design Correction
Design Correction
Failures
Clinical Trials
Customer
Failures
Prepare Technical Filefor Regulatory Body
Regulatory Certification& Approval
Failures
User Requirements Specification (URS)Design Specifications
Design Validation & Verification PlansProduct Qualification Plans
Regulatory RequirementsTechnical File
After Sales Calibration & PM End of Life Disposal
Cus
tom
er D
esig
n H
isto
ry F
ile
No
Yes
No
Yes
No
Yes
No
= Anecto involvement
Contact UsAnecto Ltd Ireland.Trusted Test ExpertsBallybrit Business Park, Galway, Ireland
Phone: +353 91 757404Fax: +353 91 757387Email: [email protected]
Anecto Scandinavia.Trusted Test ExpertsHejrevel 11, 2970 Hørsholm, Denmark
Phone: +45 45 16 17 16Fax: +45 45 16 13 19Email: Torben Taning Larsen [email protected]
Anecto Benelux.Trusted Test ExpertsPanterpad, 12 3903 XM Veenendaal, Netherlands
Phone: +31 627 435 439E-Mail: Hans [email protected]
About Anecto
ISO 11607-1
ISO 11607-2
Package and Transportation Testing
Test Equipment
Consulting Services
Product Testing
Product DevelopmentFlow Chart
Contact Us
www.anecto.com
Print \ Email \ Minimise
Trusted Test Experts
Home
