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 Development Flow Chart Contact Us www.anecto.com Print \ Email \ Minimise Trusted Test Experts Home
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.
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 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
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.
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
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
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.
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.
• Electronic systems• Mechatronic systems• Fluid Dynamic systems• Medical Equipment Test Systems• Medical Device Test Systems• Electronic measurement systems
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.
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.
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.