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Medical Engineering Technologies Ltd
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Medical device testing, we deliver technical and scientific solutions
Medical device testing, we deliver technical and scientific solutions

78 followers
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Medical Engineering Technologies Ltd's posts

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Read our latest newsletter in PDF format:
http://www.met.uk.com/uploads/images/pdfs/MET-News-April-2016.pdf
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Will you be attending the Medtec show in Stuttgart?
Do you want to discuss your design validation requirements?

Visit MET's stand. Our engineers with personal experience of developing medical devices and in-vitro diagnostics will be  available to discuss your projects. Mark Turner was a designer, developer and project manager at Smiths Medical for over 10 years prior to joining MET. Mark and our team have assembled standard Design Validation Plans for number of devices and can rapidly develop a plan specific to your needs.

Visit our stand - we know about medical devices.
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Are You Ready for the Tyvek Transition?


The Tyvek transition is almost upon us. Dupont have carried out a lot of test work on the new material production to demonstrate ‘functional equivalence’ in medical packaging applications.
MET is offering a low cost short validation protocol to allow medical manufacturers demonstrate that their existing machine qualifications are valid following the transition. The protocol includes a brief operational qualification and ageing to a single time point. Transit testing may not be required if clients can show that the seals are as strong as they were prior to the production change.

Contact for a low cost mini validation tailored to your needs, don’t get caught out!
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It’s Good To Talk

MET will be exhibiting at the MED-TECH Innovation Expo, in Coventry this year, on the 29th and 30th of April. Come and talk to us on stand 47.

At MET:
We deliver independent design validation studies for your medical device, ISO 17025 recognised and accredited.
Our knowledgeable engineers and scientists can develop efficient and effective testing protocols.
Our experience of a very wide range of devices allows us to readily understand your new development and your particular needs.
We provide comprehensive testing regimes with regular reporting.
Our easily understood reports include the detail required by regulatory authorities
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Medical Engineering Technologies is partnering in a European project aimed at developing a novel device for the quick and early diagnosis of cancer. The project is lead by the Universitat Politècnica de València

The SAPHELY project, funded by the EU's Horizon 2020 programme, is focused on the diagnosis of the four types of cancer that occur most frequently in the population and have the highest mortality rates: breast, prostate, lung and colorectal. It is estimated that these four types of cancer cause approximately 2.7 million deaths per year worldwide.

Coordinated by the Valencia Nanophotonics Technology Center of the UPV, the project proposes the development of an advanced, easy to use, low cost device that will obtain an accurate diagnosis before any significant symptoms are presented, analysing only two or three drops of blood. 

The idea To develop a device based on nanophotonic technology that enables a quick and early diagnosis of different types of cancer –specifically breast, prostate, lung and colorectal– analysing only two or three drops of blood. This is the objective of SAPHELY, a European project funded by the EU's Horizon 2020 programme, led by the Valencia Nanophotonics Technology Center of the Universitat Politècnica de València. The SYM group of Centre for Molecular Recognition and Technological Development is also participating in the project as the second partner from the UPV. 

Nanophotonics for sensing and microRNA biomarkers

The device proposed in SAPHELY enables a quick and ultra-sensitive identification of biomarkers based on microRNAs, the dysregulation of which has been linked to a large number of diseases. “The principal new feature of this unit lies in the combination of nanophotonic sensing technology and a new recognition system of those microRNA biomarkers that will enable the effect of that interaction to be amplified. This will provide an extremely high sensitivity that is not obtained with the current diagnosis systems”, highlights Jaime García, researcher at Valencia Nanophotonics Technology Center of the UPV and project coordinator. 

The sensing technique could also be implemented more easily than others used currently, in which it is necessary to carry out complex processes of labelling or sample preparation to obtain sensitivities that high. As the NTC indicates, this will lead to the possibility of obtaining very compact, light and low-cost devices; the initial cost of the reader device is estimated to be under €3,000.

Thus, SAPHELY would permit the implementation of mass screening programmes, in which the whole population at risk of a certain disease could analysed quickly and easily. “It would help diagnose the pathologies in question before any significant symptoms are presented, which would have a big impact on the quality of life of the citizens and would greatly reduce the costs met by the health systems”, indicates Jaime García.

Other applications

The researchers indicate that the SAPHELY device could also be applied to the diagnosis of a large number of diseases that have a dysregulation of certain microRNA biomarkers. Currently, more than 400 diseases linked to these dysregulations have been identified, including Alzheimer's, Parkinson's, diabetes, osteoporosis and cardiovascular disease, in addition to the different types of cancer.

And outside of the clinical sphere, they indicate that it could be used to detect pollutants in environmental resources or bacteria, pesticide, etc. in foods; the analysis of the effect of new drugs, the quick detection of chemical or biological threats, “and any other application that requires of the quick and ultra-sensitive detection of certain analytes”, concludes Jaime García.

In addition to the Universitat Politècnica de València, the project has also had collaboration from the Fundación Instituto Valenciano de Oncología-IVO, the University of East Anglia and Medical Engineering Technologies Ltd. (United Kingdom); Aalborg University (Denmark); Microfulidic ChipShop GmbH and Microtec Gesellschaft fur Mikrotechnologie MBH (Germany); APR Technologies AB (Sweden) and EV Group E. Thallner GmbH (Austria). 

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Human Factors Testing

The correct deployment of and interaction with medical devices by medical professionals and other users is a key safety consideration.

MET now delivers simulated use trials in the UK, the USA and other countries. Experienced engineers and statisticians will set up your protocol, execute the study and analyse your results. Our team can help you comply with standard IEC 62366:2007 (http://www.iso.org/iso/catalogue_detail.htm?csnumber=38594) (Medical devices -- Application of usability engineering to medical devices) and FDA Guidance, UCM 259750 (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm259748.htm) (Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design).Our studies also to take into consideration various aspects of IEC 60601, and ISO 1497 (http://www.iso.org/iso/iso_catalogue/catalogue_ics/catalogue_detail_ics.htm?csnumber=31550) Application of risk analysis to medical devices.

The studies can be applied to a very wide variety of products. Those with an electronic interface such as ventilators and blood pressure monitors, but also products such as personal lubricants or non electronic devices.

Drop us a line to hear how we can help with your design validations.

Read more here (http://www.met.uk.com/pdfs/MET-A4-1p-THAY-Medical-Info-Sheet.pdf)

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METs Medical Device Testing Laboratories to Sponsor QA Conference

MET’s Medical Device Laboratories are sponsoring the 3rd Annual Quality Assurance in Device & Diagnostic Manufacturing Conference (http://www.q1productions.com/conferencepost/euquality/#.VGDfqBFya71), Frankfurt, Germany, December 8th and9th.

The conference headline is :
Best Practices in Handling Regular & Unannounced Audits, Addressing MDR & IVDR Developments & Impact on Quality Assurance Operations, all while Exploring Efficient Strategies in Change Control Management & Process Validation

MET will be in attendance and available to discuss your development project s and testing requirements.

MET's medical device testing laboratories provide design and packaging validation studies. We are ISO 17025 accredited and staffed by engineers and scientists with experience in a wide variety of medical devices. Services include; protocol development; laboratory testing and data analysis. We can support your performance testing requirements; provide chemical analyses and sterile barrier verification. MET is the ideal choice to get your new products efficiently through regulatory approval.

MET provides laboratory services to the highest possible standards. We deliver outstanding client support through a thorough knowledge and understanding of medical devices.

Do you require electronic cigarette testing?

MET’s laboratory is exhibiting at the ‘Next Generation Nicotine Delivery conference’ (http://www.arena-international.com/nextgennicotine/). Come and talk to us about your requirements for chemical analysis of e-cigarette products and components. MET delivers a full suite of testing for the inhaled vapours, liquid materials and the ‘cigarette’ body. Child resistant packaging assessment is also available.

With the revisions to the EU Tobacco Products Directive (http://www.ec.europa.eu/health/tobacco/docs/dir_201440_en.pdf) coming into force on the 20th of May 2016, manufacturers and suppliers will be obliged to fully document their products.

Vapour producing electronic cigarettes which contain less than 20 mg/ml of nicotine and are not claimed to be medicinal products: for example as aids to smoking cessation, come under the control of the directive. In particular compliance with the following is required:

• Products are child and tamper proof.
• Health warnings, instructions for use, information on addictiveness and toxicity appear on the packaging and accompanying information leaflet.
• There are no promotional elements on packaging.
•All substances contained in the product and information on the product's nicotine content are listed.
•Existing rules regarding cross-border advertising and promotion of tobacco products, which now apply to electronic cigarettes, are adhered to.
•Manufacturers inform Member States before placing new products on the market and that they report annually to Member States.
•That a size limit for e-liquids of 10ml for dedicated refill containers and 2ml for electronic cigarette cartridges and tanks is adhered to.

Products containing more than 20 mg/ml of nicotine or which make smoking cessation claims will be prohibited unless they are licensed as medicines. These products will require authorisation by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.

More information is available from ASH (www.ash.org.uk/files/documents/ASH_937.pdf).

Come along and talk to MET about independent analysis of your products. The conference will be at the Holiday Inn London – Kensington Forum, 97 Cromwell Road, London, SW7 4DN, on the 25th and 26th of November 2014.

MET provides laboratory services to the highest possible standards and seeks to deliver outstanding client support. This relies on scientific and engineering knowledge combined with a thorough understanding of medical devices.
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