Computer assisted bone remodelling studies help prosthetic manufacturers target their product designs on particular clinical needs. Optimisation and remodelling analysis is available through MET combined with: clinical model development, FE analysis, bone density mapping, loading analysis and remodelling studies. All this leads to optimisation of geometric designs, surface features, porosity and all the details of the implant.

Material selection is a crucial element in the early stages of developing a new product. Confidence in the performance properties and storage stability is essential to allow a project to proceed efficiently. MET's environmental chambers are used by clients to provide accelerated ageing for materials which are then tested in our laboratory. We can compare properties for fresh product and aged product to provide the design inputs to move your projects forward.

Efficiency can be hard to achieve when packing medical devices into blisters. When production rates are not high many manufacturers source pre-formed blister trays externally. Lead times can be long and minimum order quantities high. In addition detailed incoming inspection is required as trays can be distorted in transport and storage and hence become more difficult to seal.

 When using the RAMAC combined tray former/sealer trays are produced on demand. This reduces the opportunity for distortion; the storage space required and inventory costs. Typically 5,000 flat sheets of rigid PETG for forming 100mm square trays might cost 250 Euro and be available within a few days. Quality goes up and costs go down, perfect.

As part of our 'excellence in medical device testing' programme MET has published an article on Endovascular Device Testing. This article will be useful to development engineers, QA engineers and regulatory professionals. It is published in the May edition of European Medical Device Technology.

The article can be found here.

MET's first priority for blister lid sealing is the seal quality. We specify only the most rigid and robust medical tray sealers. For situations requiring efficient production we are now supplying the RAMAC combined tray forming / lid sealing machine.

The RAMAC 525 work station provides an efficient platform for packing: components, orthopaedics, kits, instruments, catheters and much more. The forming tools are liquid cooled, with vacuum and air plug forming techniques. The sealing tools deliver top quality seals and the PLC retains a large number of programmes to give that extra flexibility.

No need to stock a wide range of blister trays. Forming tool changes on the RAMAC 525 are completed in just a couple of minutes.

Lid-stock and tray forming materials are available from MET also.

For more information, please use our contacts page to request a call back.

MET has a new web page describing our testing services for orthopaedic implants. Analyses include : strength and fatigue testing, wear analysis and degradation studies.

Full details can be found here.

QA testing for devices and packs is now even more accurate with the Mark 10, Series 5 advanced digital force gauges.  Tension and compression force measurement is at a peak sampling rate of 7,000 Hz, producing accurate results even for quick-action tests. Accuracy is ±0.1% of full scale ±1 digit, and resolution is 1/5000. A large, backlit LCD display shows legible characters, while the simple menu navigation allows for quick access to the gauges' many features and  parameters. Data can be transferred to a PC or other data collector via USB, RS-232, Mitutoyo (Digimatic), or analogue outputs.

Series 5 force gauges are directly compatible with Mark-10 test stands, grips, and software.

 

The EC Medical Device Directive and the Active Implantable Device Directive both now require additional clinical data, following publication of Directive (2007/47/EC), on the 21 September 2007

 Compliance is required from the 21st March 2010. Please contact MET to allow our data evaluation service to ensure your continued eligibility to sell products in Europe. Our experts will assess and report on your evaluations, investigations and post marketing data. We will provide an independent confirmation for your technical file and CE Marking or a gap analysis as appropriate.

Now sporting full PLC control the JR Maruani Temposeal medical device pouch sealing machine is available with options of heating top or bottom sealing jaws together or separately. The Siemens PLC provides accurate temperature control along the sealing bar combined with repeatable timing cycles and closing pressures. When you are producing validated pouches for sterilisation this machine combines perfectly with MET's burst test machine for confirmation of seal strength.

03/03/2010

ISO 11607 calls for qualification of a medical device's packaging system. One of the requirements is for transit testing. Two options for testing are referenced: ASTM D4169  and ISTA 2A . MET offers both options. The ASTM route is more commonly used, but the ISTA protocol offers reduced costs and when combined with MET's standard air transit approach provides all the data required to validate your packaging system.  Combine this with our sterile barrier test program and you will have your CE and FDA requirements covered.

Medical device packaging validation requires seal strength testing. MET recommends burst testing but peel strength testing is a fully accepted alternative. Our accurate calibrated equipment is ideal for carrying out this test. It provides testing, which is fully compliant with ASTM F88 -Standard Test Method for Seal Strength of Flexible Barrier Materials, allowing 180^O straight and 90^O perpendicular pull tests.

Equipment for measuring stent performance will be on display at the MEDTEC Stuttgart exhibition on the 23^rd to 25^th of March 2010. The equipment will be demonstrated by our partner Protomed and is featured on the Machine Solutions Inc Stand (stand 350). On show will be a solution for measuring radial outward force produced by cardiac and other stents. Also, information will be available on tests solutions for delivery system evaluation, and testing of durability, fatigue and retention forces.

MET has now been awarded certification to the latest quality management standard. All our products and services are controlled by our robust system, which ensures that we deliver accurate results on time.

View our certificate here.

Part of a good regulatory strategy encompasses toxicological risk assessment. This should be performed in accordance with the guidance provided in ISO 14971 (application of risk management to medical devices).

Experts at MET can analyse your product and its application to develop a risk assessment and regulatory strategy to get you to market quickly. Information from the risk assessment leads into informed safety testing and the correct application of ISO 10993. This minimises the test requirements and hence project timescales.

Tensile, compression and torque testing are all important features of medical device development and QA. MET now delivers and supports a wide range of equipment, which is perfectly adapted testing product strengths and performance. Why not visit our new web page?

The MiniBurst pack seal strength tester is now available from stock. Simply call us to arrange delivery of this handy piece of equipment. It takes up very little space and makes a perfect QA gauge for medical device pack strength testing. The MiniBurst is also perfect for validating packages and packaging machines.

 It addresses your sterile barrier seal strength testing needs from ISO 11607 and ASTM F 1140.

Development of class 1 through to class III devices require a well thought out plan to satisfy all the regulatory requirements. MET can now offer very well informed regulatory consultancy for all classes of device. Our regulatory service delivers up to the minute advice for: medical devices, active implantable devices and in vitro diagnostic devices.

Rely on us for your: regulatory strategy, design verification, risk assessment, Notifications and Technical Files, 510k, IDE and PMA. We can take you to 'first in man' and onto the market.

MET's medical device testing laboratory has moved to a new home. You will still get the same rapid, efficient service from our knowledgeable scientists and engineers.  Integration of our office and laboratory services reinforces our control systems and reporting efficiency.

 

The new laboratory is situated at:

 

Medical Engineering Technologies Ltd.,

Yew Tree Studios,

Stone Street,

Stanford North,

Ashford, Kent

TN25 6DH.
UK

MET is presenting on medical device and stent testing at the 'Medical Device Manufacture - Fine cutting / Precision Manufacturing' workshop. The meeting is to be held by the Association of Laser Users at Manchester University on the 24^th of November.

This workshop offers the opportunity for "supply chain" networking in the design and manufacture of stents and indeed all medical devices. It also addresses key technical and clinical issues in micron-scale laser processing and in the manufacture and qualification of medical products in general.

A full range of tensile and torque testing equipment is now available from MET. Fully calibrated gauges and test stands can be applied to a wide variety of test situations.

 Torque testing for: lid closure forces, catheter force transmission responses, tear open/ off forces and much more

 Tensile testing for: bond strengths, pack seal strengths, tubing strength and much more.

 Compression testing for: connector security, packaging security, actuator resistance and much more.

Further additions to MET's tensile testing facilities now allow full examination of orthopaedic products. As well as endurance and repetitive strain studies we can now offer tensile testing up to 20kN. The equipment is also suitable for compressive tests, torsion tests and shear performance analysis.

 

Whatever your medical device MET has the testing solutions for you. We can provide complete solutions including biological safety, functional testing, packaging testing and computer modelled stress strain analyses.

 

Shelf life and product stability studies require accelerated ageing to allow functional testing after the recommended shelf life period. If you do not want to wait 5 years for the results, that is!

MET's laboratory is equipped with ageing chambers running at a variety of temperatures. Our accelerated ageing programme can be tailored to your product's thermal properties. For heat labile materials we have chambers running at 40^OC. Whilst for those more robust materials we can age at 85^OC. At this higher temperature according the Arrhenius equation the equivalent of 1 year worth of real time aging can be delivered in achieved in under a week.

The medical pouch making machines produced by our partner JR Maruani will be on display at this year's Compamed exhibition.

These easy to maintain machines have been delivering robust and reliable clean room production for over 25 years.

They can be seen at: COMPAMED 2009 International Trade Fair in Düsseldorf 18-20.11.2009
Stand M41 Hall 8A

 

Functional testing is an important part of medical device development. Sophisticated test equipment now allows high speed video recording of a vascular products to be recorded whilst measuring their dynamic performance on the bench. Example footage is available on request from MET. It shows a fluid dynamics investigation using tracer particles and laser interrogation. Videos are also available showing the testing of delivery systems. The footage shows the catheter in artificial vasculature whist advancement and forces are being measured as described in : ISO Standard 25539-1:2003(E)  "Cardiovascular Implants - Endovascular Devices".

MET has published an article in the current edition of Medical Device Technology magazine (September 2009).

The article describes all the current methods for leak testing medical devices and gives examples of their practical application for product and package testing.

 You can read the article here.

Our laboratory testing services have been expanded with our latest equipment purchase. Medical devices can now be tested at elevated or reduced pressures in our pressure chambers. This testing is useful for examining the performance of products at altitude, in places such as Mexico City or in airplanes. It is also useful for high pressure situations.

 

 

 

The new fully featured, PLC controlled pouch sealer is now available for packaging medical devices. If you are packing medical devices into pouches for terminal sterilisation, this machine is perfect for you.

 The latest version of the JR Maruani Temposeal uses a heated bar to weld pouch seals. The temperature is controlled and monitored by a Siemens PLC, giving precise control and information. Dwell time and closing pressure are also tightly controlled and displayed. All the information for validating production is easily available.

 

 

MET has a range of  'off the shelf' solutions for examining ostomy pouch performance.

These include: specifically designed leak test systems; package validation programs; and skin adhesive biocompatibility studies.

 

Automated 100% in-line leak testing equipment for impermeable packs is available from MET. This equipment fits to the end of your packaging line and automatically verifies pack seal integrity. It can operate at up to 15 packs per minute.

At MET we have been expanding our laboratory equipment line up. We have invested in new tensile testing equipment and can now offer a maximum test force of 5kN with a displacement speed of 300mm per minute. In addition to peel testing, bond strength testing and product testing we can now also test standard plastic samples to ISO 527.

MET is setting up to provide testing for walking aids, wheel chairs and mobility aids. Please let us know about your requirements.

 

Heart valve testing services available from MET are now detailed on our latest web page. Test benches for custom and standard testing services are described. This is a comprehensive service covering all the requirements for mechanical and biological valves and novel delivery systems.

 Heart Valve Testing

 

Engineers at MET have a wide variety of expertise in designing and testing medical devices. Our totally integrated platform allows us to combine design services using CAD and FEA, with knowledgeable risk analysis and functional testing. It does not stop there, as we can assess product performance against consensus standards and deliver all the data required for technical files and product approval. When required we also have in vivo facilities for phase 1 testing. Our regulatory consultants are on hand to help with CE marking and FDA submissions.

 Use our integrated design and testing services to save time and money, accelerate your medical device projects.

 

 

Hydrogen gas medical device and package leak testing equipment from MET has been upgraded. Version 5 of the Sensistor H2000 PLUS V5 has been released, delivering the highest sensitivity and best performance ever!

 

 Medical device leak testing equipment is now available for rental from MET.

This includes: pressure testing equipment, 'blue dye' testers and hydrogen trace gas testers

 

The medical device packaging machines from MET can now be seen on You Tube. The video footage shows a two lane glove packaging machine operating totally automatically at 60 cycles per minute.

http://www.youtube.com/watch?v=LsZverXFVjo

 

 

Medical tray sealers have been evolving at Belco. They still retain the rigid structure and precise control, now with added interfacing options and control systems. These include: 

• Wireless Bar code scanning for the input of process data
• Data Acquisition of all characteristics for every seal cycle
• Networking of multiple machines for data recording

 

 

The MET Vacuum Package Leak Test equipment is now available with extra precision. Making the leak integrity testing of tablet blisters and low viscosity fluid filled containers even more accurate.

 

 

Medical device package stability testing requires both accelerated aging and real time aging studies to validate shelf life claims. MET is now offering real time aging studies in conjunction with accelerated test programs free of charge. Test programs include aging, integrity testing and seal strength testing.

 

A new series of brochures describing medical device testing services is now available from MET. Titles include

Endovascular Device Testing

Heart Valve Testing

Stent Retention Force Testing

Stent Functional and Fatigue Testing

Contact MET for your copy.

8 June 2009

 

Stent delivery systems must deploy their cargo at the desired location. ASTM F2394 - 07 'Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System' is a guide to measuring the security of a stent on its balloon to ensure safe delivery. MET now provides comprehensive testing to this standard.

Fatigue testing, standards compliance, flow characteristics: a complete range of tests for heart valves is now available from MET. We examine valve opening pressures, forward flow, back flow, pulsatile flow and much more.

 

"The testing for IV Bag for pressure decay last time was smooth and successful, we are satisfied by the prompt and detailed report." Honk Kong Pharmaceutical Company, QA Lab.

Shelf life claims validation forms part of a  comprehensive range of medical device and pack testing that is available from MET. A recent article in the spring edition of Med-Tech Packaging News by Mark Turner (MET) describes the application of these tests under FDA guidance.

 

MET's supplier of blister tray sealing equipment, Belco Packaging Systems Inc., is celebrating its fiftieth birthday. Belco's medical tray sealers are robustly delivering perfectly sealed blister in factories around the world, day in day out. They are used for packaging a wide range of medical devices, from arthroscopy to orthopaedics

 

MET is now able to provide the full gamut of testing required in ISO25539:2003 Cardiovascular implants. Testing covers both part 1: Endovascular Prothesis and part 2: Vascular Stents. Insertion forces can be measured as well as trackability and pushability for percutaneous devices. Radial outward force measurement and fatigue testing is carried out on the stents.