Medical Software Standard IEC 62304 Ready for World Stage

The ratification and update of IEC 62304, a standard for the design of medical products recently endorsed by both the European Union and the United States, has prompted medtech developers to wonder if IEC 62304 might not have the outlines of a global medical device standard. A universal development process that ensures the safety and quality of medical devices is needed, write LDRA’s Anil Kumar, a technical consultant based in India, and Mark Pitchford, Field Applications Engineer, in an article published on medicalelectronicsdesign.com.

IEC 62304 can be the foundation of such a process, they add in “Easing IEC 62304 Certification for Medical Devices.” They also look at how to bring legacy products into compliance in the article.

The first part of this two-part article is now available on the MED website.

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Patient Monitoring Via the Cloud Has Sunny Future in India, Says Isansys CEO

The LifeTouch Patient Surveillance System, developed by UK company Isansys Lifecare, reportedly is the first cloud-ready product to be certified as a Class IIa medical device under the terms of Europe’s Medical Devices Directive. The CE-marked system can now be used clinically within the European Union, but company CEO Keith Errey has far greater ambitions for his device. The United States is a target market . . . as is India. Read more…

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India-UK ICT Collaboration Receives £10 Million in Funding

The India-UK ICT research collaboration is £10 million richer today, and some of that money will benefit rural healthcare initiatives on the subcontinent. The funding was announced on 18 April by UK Minister for Universities and Science David Willetts during a meeting with Indian Science and Technology Minister Vilasrao Deshmukh in London. Read more…

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Sun Pharma’s Asthma and COPD Inhaler Among Finalists for 2012 MDEA Awards

Combitide Starhaler, a dry powder inhaler for asthma and chronic obstructive pulmonary disease patients, is one of the finalists of the 2012 Medical Design Excellence (MDEA) awards. The inhaler, manufactured by Sun Pharma Advanced Research Company Ltd (Mumbai), is nominated in the General Hospital Devices and Therapeutic Products category. Read more…

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Developed and Emerging Medtech Markets Benefit from Innovation Made in India

The MD&M India conference provides medical device OEMs with unprecedented access to key leaders in the medical technology community as well as a unique opportunity to gain new insights into the dynamics of this remarkable industry. Leading up to the event, which will be held in Mumbai from 23 to 25 May 2012, medtechinsider India will publish a series of articles and interviews with the aim of contextualising some of the issues that will be explored at the conference. We are delighted to start this series in the company of Ajay Pitre, Managing Director at the Sushrut-Adler Group, which manufactures and distributes orthopaedic products. Read more…

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Gerresheimer Acquires Neutral Glass in India

German firm Gerresheimer is on a shopping spree. I met with the Düsseldorf-based company at MEDTEC Europe last month to learn more about its recent acquisition of design bureau item GmbH. I’m barely back in the office when I learn that the supplier of glass and plastic products to the global life sciences industry has acquired majority shares in Indian company Neutral Glass & Allied Industries Pvt. Ltd. The move is touted as one more manifestation of Gerresheimer’s commitment to growth in emerging economies. Read more…

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GE Healthcare’s India Strategy Poised to Pay Off

GE Healthcare will launch about 20 new products to be developed in India this year, reports Forbes. The company’s efforts in the country where it spends about US$50 million on R&D annually are finally set to yield results, according to the article titled “GE Healthcare’s India Centre Is a Model of Its Emerging Markets Strategy.” Read more…

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Mumbai to Host Medical Manufacturing Conference

MD&M, the world’s leading medical manufacturing event, is coming to India for the first time in May. Taking place in Mumbai from 23 to 25 May 2012, MD&M India will provide medical device OEMs with unprecedented access to key leaders in the medical technology community. The schedule is as follows: Read more…

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Rental Schemes Drive Biochemistry Instruments and Reagents Market in India

The trend of placing high-end analysers under reagent rental schemes is gaining momentum in India. It is expected to be the prime factor driving the growth of India’s biochemistry instruments and reagents market. Read more…

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Aptar Pharma Sets Up Production Near Mumbai

From the wire: Aptar Pharma, which develops and manufactures nasal and pulmonary drug-delivery devices, has announced the opening of a new facility near Mumbai, India.

Located at Rabale, Navi Mumbai, the new site includes an ISO Class 7 cleanroom, which will be used primarily to produce the DF30 metering valve platform for metered dose inhalers and to assemble spray pumps. Read more…

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