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Radisens Diagnostics is expanding its product and process development teams to extend the test menu offering on its proprietary diagnostic platform. The successful candidates will demonstrate a mix of skills, with industrial experience in a relevant in-vitro diagnostics (IVD) product development or process development environment a distinct advantage.

Available Vacancies:

  1. Quality/Regulatory Affairs (QA/RA) Manager

 


Quality/Regulatory Affairs (QA/RA) Manager

Job Functions

  • Become a leading member of Radisens’ team developing the next generation of point-of-care in-vitro diagnostic platforms,
  • Drive and Implement the Design Control process for Radisens’ innovative platform in accordance with FDA 21 CFR Part 800, ISO 13485 and ISO 14971,
  • Review, update and manage the existing Design Control System within QMS,
  • Establish and maintain Design History Files (DHF) and carry out Risk Management,
  • Work closely with Radisens’ multidisciplinary teams of clinical scientists, engineers, software developers in a highly innovative and interactive environment.

Required Skills and Experience

  • Primary/Higher Degree in relevant discipline with 5+ years relevant industrial experience,
  • Experience in Design Control and Quality Management within the In Vitro Diagnostics (IVD) Sector in a senior position,
  • Knowledge of Corrective and Preventive Action (CAPA) processes and implementation,
  • Knowledge of Good Document Practise (GDP) and Good Manufacturing Practise (GMP) requirements,
  • Experience of the following is essential:
    • FDA 21 CFR Part 800, ISO 13485,
    • Writing and maintenance of Design History Files,
    • Risk Management in line with the requirements of ISO 14971.
  • Experience of clinical chemistries, point of care technology, instrumentation,
  • Self-starter with demonstrated ability to work in a multi-disciplinary and deadline-driven environment with an analytical approach to problem-solving,
  • Experience of ISO requirements, GMP guidelines and regulatory approval processes,
  • Supplier Management,
  • Experience with product development cycle and manufacturing scale-up processes,
  • Excellent oral and written communication skills,
  • This role may require national and/or international travel.

Radisens Diagnostics Ltd. is an equal opportunities employer.

Candidates should apply online, using reference QARA-S01. Strictly no agencies.

 

Radisens Diagnostics Ltd. is an equal opportunities employer.

Candidates should apply online, using reference ASSAY-D04. Strictly no agencies.

Radisens wins Red Herring Top 100 Europe Award

Cork – April 14, 2016Radisens Diagnostics announced today it has won the Red Herring Top 100 Europe award, a prestigious award recognizing Europe’s leading private companies and celebrating these startups’ innovations and technologies across their respective industries.

Red Herring Top 100 Europe enlists outstanding entrepreneurs and promising companies. It selects the award winners from approximately 1,200 privately financed companies each year in the European Region. Since 1996, Red Herring has kept tabs on these up-and-comers. Red Herring’s Top 100 list has become a mark of distinction for identifying promising new companies and entrepreneurs. Red Herring’s editors were among the first to recognize that companies such as Alibaba, Facebook, Google, Kakao, Skype, SuperCell, Spotify, Twitter, and YouTube would change the way we live and work. Thousands of the companies most interesting and innovative companies have graced the Top 100 list over the years.

Red Herring’s editorial staff evaluated the companies on both quantitative and qualitative criteria, such as financial performance, technological innovation, management quality, overall business strategy and market penetration. This assessment was complemented by a review of the track records and standings of similar startups in the same verticals, allowing Red Herring to see past the “buzz” and make the list a valuable instrument of discovery and advocacy for the most promising new business models in Europe.

The Red Herring editorial team selected the most innovative companies from a pool of hundreds from across Europe. The nominees were evaluated on 20 main quantitative and qualitative criterion: they include disruptive impact, market footprint, proof of concept, financial performance, technology innovation, social value, quality of management, execution of strategy, and integration into their respective industries.

About Radisens Diagnostics

Radisens, a private venture-backed diagnostics company, is breaking new ground in the decentralisation of routine blood testing from central reference laboratories into physician offices, outpatient clinics, pharmacies and other near-patient test settings. With a finger-prick of blood, this multi-mode diagnostic device will return laboratory-grade results instantly within a patient’s physician visit.

Radisens’ initial menu concentrates on panels for those suffering with high-burden chronic disease resulting in improved patient outcomes and more efficient healthcare management. By integrating immunoassay, clinical chemistry, cell counting and other test modes, this near-patient device will finally open blood testing access to all with instant diagnosis and monitoring. The fear or needles, the many anxious days or weeks of waiting for results, the multiple physician visits, will all be things of the past.

Radisens awarded €4.5M for diabetes menu development

€4.5M award for diabetes menu development

EC funding to integrate diabetes, cardiovascular & kidney function test panels

Cork – Jun 23, 2015 – Radisens Diagnostics, a medical diagnostics company developing a near-patient device to instantly test for high-burden chronic disease anywhere, announced today that it has been awarded a €4.5m grant from the European Commission’s SME Instrument initiative. As part of the EC’s Horizon 2020 Research and Innovation programme, the €3bn SME Instrument hand-picks potentially disruptive businesses to invest and support.

“We are delighted with this significant endorsement from the EC, in support of our vision of instant testing of any high-burden chronic disease anywhere”, commented Radisens’ CEO, Jerry O’Brien. “Integrating diabetes, cardiovascular and kidney function panels onto Gemini™ will impact people’s daily lives”. Radisens will use the funds to integrate such panels on to its Gemini™ near-patient platform, giving instant results from a fraction of a drop of blood.

Near-patient blood testing is one of the fastest growing segments of the healthcare industry, fuelled by the push towards improving patient outcomes, healthcare efficiencies and quality standards. It closes the linkage between diagnostics and therapeutics, as current lab tests require days before results are available. O’Brien adds, “Radisens’ vision is that of a confirmed diagnosis, clinical counselling and prescribed therapies all within a single physician or pharmacy visit, without fear of needles or anxious days of waiting for results, thereby empowering patients to better manage their chronic disease”.

About Radisens Diagnostics
Radisens, a private venture-backed diagnostics company, is breaking new ground in the decentralisation of routine blood testing from central reference laboratories into physician offices, outpatient clinics, pharmacies and other near-patient test settings. With a finger-prick of blood, this multi-mode diagnostic device will return laboratory-grade results instantly within a patient’s physician visit.

Radisens’ initial menu concentrates on panels for those suffering with high-burden chronic disease resulting in improved patient outcomes and more efficient healthcare management. By integrating immunoassay, clinical chemistry, cell counting and other test modes, this near-patient device will finally open blood testing access to all with instant diagnosis and monitoring. The fear of needles, the many anxious days or weeks of waiting for results, the multiple physician visits, will all be things of the past.

About the EC’s Horizon 2020 & SME Instrument
Horizon 2020 is the biggest European Commission Research and Innovation programme ever with nearly €80bn of funding available over 7 years (2014 to 2020). Horizon 2020 funds high-potential innovation through a dedicated SME instrument. Provided with about €3bn in funding over the period, the SME Instrument helps high-potential SMEs to develop groundbreaking innovative ideas for products, services or processes that are ready to face global market competition. Available to SMEs only, the new scheme has opened a new highway to innovation through phased, progressive and complimentary support.

The dedicated SME instrument’s supports close-to-market activities, with the aim to give a strong boost to breakthrough innovation. Highly innovative SMEs with a clear commercial ambition and a potential for high growth and internationalisation are the prime target. More details are available at the Horizon 2020 SME Instrument portal.

Commercial Contact:
Jerry O’Brien, Radisens Diagnostics Ltd.
E: info (at) radisens.com
T: +353 21 233 9140

Radisens to attend J.P. Morgan Conference and present at OneMedForum

Cork – Jan 2, 2015 – Radisens Diagnostics’ management will make their annual pilgrimage to attend the 33rd J.P. Morgan Healthcare Conference in San Francisco from 12th-15th Jan 2015. This invitation-only event is the world’s largest annual healthcare investor conference.

Additionally, Radisens has been selected to present at the OneMedForum conference, which runs concurrently with the J.P. Morgan conference. OneMedForum is an industry summit focusing on partnering with, and investment in, select high growth healthcare SME’s.

“We are honored to be chosen as one of the high growth potential companies presenting”, said Jerry O’Brien, CEO. “The conference provides an excellent venue for Radisens to showcase our vision of instant blood testing for all at the point of care, our progress so far and how this pioneering work will improve patient outcomes and reshape blood diagnostics forever”.

Radisens features on CNN’s ‘Make, Create, Innovate’

Cork – Dec 29, 2014 – Radisens Diagnostics will be featured this week on CNN’s science and technology series ‘Make, Create, Innovate‘, as part of CNN International’s primetime business show ‘Quest Means Business’. The feature will broadcast this Tuesday, 13th January, from 21:00 GMT on CNN International.

Make, Create, Innovate is dedicated to science and technology, telling stories behind the inventions and technological breakthroughs that are reshaping the world. Radisens’ CEO will offer insights on his vision of instant blood testing for all, the journey so far and how this pioneering work will reshape blood testing forever.

The show broadcasts into more than 280 million homes around the world and streams online at CNN.com, which receives more than 10 million views daily.

Radisens announces second €1M contract with European Space Agency

Cork – May 14, 2014 – Radisens Diagnostics has been awarded a second €1m contract by the European Space Agency (ESA) to develop an innovative blood testing device for use by astronauts on board the International Space Station and on various human spaceflight missions. This builds upon their initial partnership announced back in November 2011.

The European Space Agency has contracted Radisens to extend the blood testing menu on their point-of-care device which is currently in development at their facility at the Rubicon Centre, Cork. This forerunner device could be used on board the International Space Station and on various human spaceflight missions where it is essential to get high-performance, laboratory grade results for myriad health conditions, without fear of biological contamination.

Radisens’ CEO, Jerry O’Brien, commented “We are delighted to extend our successful partnership with ESA. The operational needs on board the International Space Station, which requires leading-edge performance, ease-of-use and biological containment, provide Radisens with a unique test-bed for our game-changing point-of-care platform”.

Congratulating the company, Sean Sherlock, TD, Minister for Research and Innovation and the Minister with policy responsibility for space matters said “Radisens is another excellent example of how innovative Irish companies are leveraging the Irish Government’s investment in the European Space Agency. Space is proving to be a very fertile ground for Irish companies in developing innovative technologies and proving the technologies performance in extreme environments. The Radisens example also clearly shows how technologies developed for space can have a major societal impact here on Earth in improving human healthcare. We want to see indigenous companies like Radisens scale up and grow to create jobs here in Ireland, and winning internationally benchmarked contracts like this will help them achieve this”.

ESA’s Technical Officer, Francois Gaubert, added “Performing rapid analysis of astronauts’ blood samples and monitoring their physiological parameters onboard the ISS without having to download the samples from the ISS to the ground laboratories is a feature with utmost interest that the RADISENS POC proposes to develop”.

Tony McDonald, Enterprise Ireland pointed to Radisens as one of a growing number of Irish companies which are looking to ESA to support their product and market development strategies. The partnership with ESA is proving to be highly beneficial to Irish companies in supporting technology development, product reliability and performance and in providing a globally recognised reference customer.

About Radisens Diagnostics
Radisens Diagnostics, a venture-backed diagnostics company, is breaking new ground in the decentralization of routine blood testing from central reference laboratories into physician offices, outpatient clinics, hospital bedsides and other point-of-care settings. With a finger-prick of blood, this multi-mode diagnostic device will return laboratory-grade results within minutes during a patient’s physician visit.

Radisens’ initial applications will concentrate on test panels to provide clinical benefits for more efficient chronic disease management. A single sample-to-result analyzer, this IP protected platform will provide a step improvement in blood test performance, and will remove the many anxious days or weeks of waiting for routine blood test results, provide better patient outcomes and introduce much needed efficiencies into healthcare systems worldwide.

About Enterprise Ireland and the European Space Agency
The European Space Agency (ESA) is the intergovernmental organisation that promotes co-operation among European States in space research and technology and their space applications for scientific purposes and for operational space applications systems. Ireland’s membership of ESA permits Irish companies and research teams to bid for ESA contract development work in a range of space programmes.

Enterprise Ireland is the Irish body responsible for co-ordinating Ireland’s industrial and research participation in the programmes of ESA. Its role is to assist Irish companies to successfully bid for ESA contracts. Enterprise Ireland provides a source of expertise for Irish companies in developing and executing space strategies, Irish industrial participation is primarily in the engineering, aerospace, software, electronics, optoelectronics and telecommunications sectors.

The level of spin off export sales (including direct ESA contracts) from Irish investment in ESA is estimated at €50m in 2013 and projected to grow substantially as the number of Irish companies securing ESA contract continues to expand, and as existing Irish ESA contractors progress from intensive R&D phase to commercial exploitation phase.

Commercial contacts:
Jerry O’Brien
Radisens Diagnostics Ltd.
E: info (at) radisens.com
T: +353 21 4868195

Radisens’ Point-of-Care Diagnostic Platform delivers third-generation TSH performance

Cork – Nov 06, 2013 – Radisens today announced that key performance targets have been achieved for immunochemistry tests on its pioneering Point-of-Care diagnostic platform. The most demanding parameter for immunochemistry tests today is sensitivity and Radisens decided early in the product development lifecycle to strive for a laboratory grade gold standard, well accepted by industry, namely 3rd generation TSH. Immunochemistry is one of the core modes alongside clinical chemistry, turbidimetry and cell counting on this broad multi-modal platform.

The claims are based on functional sensitivity data from Radisens’ thyroid function test, commonly referred to as thyroid-stimulating hormone (TSH), which is one of the most frequently ordered blood tests by physicians. Defined by a functional sensitivity of 0.01mIU/L (or 2.5 pg/mL), third-generation performance is clinically relevant for patients with various thyroid disorders such as hyperthyroidism, hypothyroidism, sub-clinical abnormalities, for monitoring those on hormone replacement therapy, or prior to administering contrast agents during imaging procedures. With over five decades of dynamic range, the Radisens platform can span the clinically relevant range from the 3rd generation limit of detection right up to the high TSH concentrations that untreated hypothyroidism sufferers can experience.

Radisens’ CEO, Jerry O’Brien, commented “Incumbent Point-of-care devices have suffered from inferior performance compared with the central laboratory. Our three-pillar strategy of delivering market-leading performance across the most demanding blood tests, integrating multiple blood-testing modes into a single connected device, and reducing operating costs will set us apart in the point-of-care market”.

This multi-mode device will replace the myriad stand-alone instruments that a physician would typically require for routine blood testing. The device requires a fraction of a blood drop and delivers multi-mode clinical results within minutes. Initial chronic disease test menu will include panels for diabetes, heart disease, thyroid function, kidney disease and cell counting.

About Radisens Diagnostics
Radisens Diagnostics, a venture-backed diagnostics company, is breaking new ground in the decentralization of routine blood testing from central reference laboratories into physician offices, outpatient clinics, hospital bedsides and other point-of-care settings. With a finger-prick of blood, this multi-mode diagnostic device will return laboratory-grade results within minutes during a patient’s physician visit.

Radisens’ applications at launch will concentrate on test panels to provide clinical benefits for more efficient chronic disease management. A single sample-to-result analyzer, this IP protected platform will provide a step improvement in blood test performance, and will remove the many anxious days or weeks of waiting for routine blood test results, provide better patient outcomes and introduce much needed efficiencies into healthcare systems worldwide.

Commercial contacts:
Jerry O’Brien
Radisens Diagnostics Ltd.
E: info (at) radisens.com
T: +353 21 4868190 / Fax: +353 21 4928909

Frost & Sullivan recognises Radisens with 2012 Technology Innovation Award

London – Nov 29, 2012 – Based on its recent analysis of the integrated point-of-care (POC) diagnostic platforms market, Frost & Sullivan recognises Radisens Diagnostics Limited with the 2012 European Technology Innovation Award. Realising the onward surge to integrate POC instruments covering multiple blood test categories, Radisens is developing a single connected multi-diagnostic device, based on its proprietary technology, for long-term chronic disease management. (View the full analyst report here).

“Radisens’ miniaturised POC device and consumable platform integrates different combinations of multiplexed high-sensitivity immunoassays, clinical chemistries, and haematology (cell counting) assays onto single consumable panels,” explained Frost & Sullivan Healthcare Industry Analyst Prasanna Vadhana Kannan. “These panels initially target long-term chronic disease management of thyroid disorders, chronic diabetes, cardiovascular disease, chronic kidney disease, and cell counting.”

This single device thereby effectively replaces the ten to fifteen stand-alone instruments that a physician would typically require for routine blood testing. Moreover, the interpretation of lab-grade data is instantaneous. All sample preparation and blood testing procedures are integrated into the test panel, thereby enabling accurate, highly sensitive, repeatable, sample-to-answer and quality assured results.

“Radisens’ technology platform is truly considered disruptive,” added Kannan. “It seamlessly converges consumer electronics, centrifugal microfluidics, and assay development to achieve smart decentralisation of medical diagnostics from a central reference laboratory into POC settings.”

This platform requires only a finger prick of blood and can deliver clinical results within minutes of blood draw. Through this approach, patients are more likely to improve prescription compliance and, in turn, significantly contribute toward a reduction in the risk factors for chronic disorders. This will impart healthcare systems globally with a much needed tool to combat rising chronic disease management costs.

Notable features that distinguish Radisens’ solution from other competing POC devices in the market include: all assay and sample preparation steps integrated onto a consumable panel, central reference laboratory performance, solid-state digital detection, analyte microanalysis algorithms, and, a single integrated device platform capable of multiplexed diagnostics across the three primary blood test categories of immunoassays, clinical chemistries and cell counting.

“Overall, the potential for Radisens’ diagnostic platform based on its real-time connectivity, sample-to-answer operation, high-degree of multiplexing, and low cost features is immense and is poised to revolutionise the integrated POC diagnostics market,” concluded Kannan.

Frost & Sullivan presents this award to the company that has demonstrated excellence in terms of the uniqueness of its technology and its potential impact on new products/applications, on functionality and on customer value. The company is also commended for the relevance of this innovation to industry.

Frost & Sullivan Best Practices awards recognise companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research to identify best practices in the industry.

About Radisens Diagnostics
Radisens Diagnostics, a venture-backed diagnostics company, is breaking new ground in the decentralization of routine blood testing from central reference laboratories into physician offices, outpatient clinics, hospital bedsides and other point-of-care settings. With a finger-prick of blood, this multi-mode diagnostic device will return laboratory-grade results within minutes during a patient’s physician visit.

Radisens’ applications at launch will concentrate on test panels to provide clinical benefits for more efficient chronic disease management. A single sample-to-result analyzer, this IP protected platform will provide a step improvement in blood test performance, and will remove the many anxious days or weeks of waiting for routine blood test results, provide better patient outcomes and introduce much needed efficiencies into healthcare systems worldwide.

About Frost & Sullivan
Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants.

Our “Growth Partnership” supports clients by addressing these opportunities and incorporating two key elements driving visionary innovation: The Integrated Value Proposition and The Partnership Infrastructure.

  • The Integrated Value Proposition provides support to our clients throughout all phases of their journey to visionary innovation including: research, analysis, strategy, vision, innovation and implementation.
  • The Partnership Infrastructureis entirely unique as it constructs the foundation upon which visionary innovation becomes possible. This includes our 360 degree research, comprehensive industry coverage, career best practices as well as our global footprint of more than 40 offices.

For more than 50 years, we have been developing growth strategies for the global 1000, emerging businesses, the public sector and the investment community. Is your organization prepared for the next profound wave of industry convergence, disruptive technologies, increasing competitive intensity, Mega Trends, breakthrough best practices, changing customer dynamics and emerging economies?

Commercial contacts:
Jerry O’Brien
Radisens Diagnostics Ltd
E: info (at) radisens.com
T: +353 21 4868190 / Fax: +353 21 4928909

Emily Bailey
Best Practices, Frost & Sullivan
E: emily.bailey@frost.com
T: +44 (0)20 7915 7869

Radisens selected for Healthcare Innovation Hub pilot

Cork, Ireland – July 23, 2012 – Radisens Diagnostics announced today that it has been selected as one of only six companies to partake in the recently announced National Healthcare Innovation Hub (HIH) pilot. Launched last week by the Taoiseach, Tánaiste and the Minister for Jobs, Enterprise and Innovation, the HIH will support the generation, development, validation, evaluation and implementation of new healthcare innovations. This involves the Health Service Executive (HSE) and high-tech companies collaborating to provide an effective route for new healthcare innovations from industry to access the HSE.

As part of the HIH, Radisens is planning a clinical reference testing site in partnership with the HSE and local hospitals. Access to the local healthcare system will allow the company to test and validate their advanced point-of-care technology in a controlled and regulated environment ahead of commercial launch. With Ireland spending up to €1.45 billion annually on managing chronic diabetes alone, the clinical reference site will pilot the design and efficient integration of this disruptive technology, which promises huge savings for chronic disease management.

About Radisens Diagnostics
Radisens Diagnostics, a venture-backed diagnostics company, is breaking new ground in the decentralization of routine blood testing from central reference laboratories into physician offices, outpatient clinics, hospital bedsides and other point-of-care settings. With a finger-prick of blood, this multi-mode diagnostic device will return laboratory-grade results within minutes during a patient’s physician visit.

Radisens’ applications at launch will concentrate on test panels to provide clinical benefits for more efficient chronic disease management. A single sample-to-result analyzer, this IP protected platform will provide a step improvement in blood test performance, and will remove the many anxious days or weeks of waiting for routine blood test results, provide better patient outcomes and introduce much needed efficiencies into healthcare systems worldwide.

Commercial contact:
Jerry O’Brien
Radisens Diagnostics Ltd.
E: info (at) radisens.com
T: +353 21 4868190 / Fax: +353 21 4928909

Radisens and Beckman Coulter sign Collaborative Development and Evaluation Agreement

Cork, Ireland – May  29, 2012 – Radisens Diagnostics and Beckman Coulter, Inc. have announced that they have entered into a Collaborative Development and Evaluation Agreement to exploit Radisens Diagnostics’ proprietary platform technology for cellular analysis applications.

Comprising part of Radisens point-of-care diagnostic platform, the proprietary digital HDR™ detection engine delivers industry leading multi-colour fluorescence and scattering sensitivity. This matchbox-sized HDR™ detection engine delivers a step-change in the market for portable multi-fluorescent flow cytometers, cell analysers and diagnostic devices. The six decades of optical dynamic range enables truly automatic sample-to-answer operation, with the digital solid-state technology removing the need for expensive maintenance cycles, while significantly reducing instrument cost.

Jerry O’Brien, CEO of Radisens Diagnostics said, “This strategic collaboration with Beckman Coulter demonstrates the disruptive nature of the diagnostics technology that we are developing at Radisens in terms of performance, cost and usability. This opens up huge growth opportunities in providing clinicians and researchers a powerful, low-cost diagnostic tool onto their desk with the advanced laboratory performance they require.”

Commenting on the deal, Mario Koksch, Director Product Management for Flow Cytometry at Beckman Coulter, Inc., said “We are very excited by the potential performance, cost and usability benefits that Radisens can bring with its proprietary HDR™ detection technology. We look forward to realizing the huge potential this offers within emerging high-growth flow cytometry markets, while maintaining a reputation for high performance.”

About Radisens Diagnostics
Radisens Diagnostics, a venture-backed diagnostics company, is breaking new ground in the decentralization of routine blood testing from central reference laboratories into physician offices, outpatient clinics, hospital bedsides and other point-of-care settings. With a finger-prick of blood, this multi-mode diagnostic device will return laboratory-grade results within minutes during a patient’s physician visit.

Radisens’ applications at launch will concentrate on test panels to provide clinical benefits for more efficient chronic disease management. A single sample-to-result analyzer, this IP protected platform will provide a step improvement in blood test performance, and will remove the many anxious days or weeks of waiting for routine blood test results, provide better patient outcomes and introduce much needed efficiencies into healthcare systems worldwide.

About Beckman Coulter
Beckman Coulter, Inc., based in Orange County, CA, develops, manufactures and markets products that simplify, automate and innovate complex biomedical tests. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on six continents. For more than 75 years, Beckman Coulter products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care. For more information, visit www.beckmancoulter.com.

Commercial contact:
Jerry O’Brien
Radisens Diagnostics Ltd.
E: info (at) radisens.com
T: +353 21 4868190 / Fax: +353 21 4928909