Archive for the ‘Regulation’ Category
Wednesday, September 1st, 2010
The debate on the reuse of single-use devices, which flares up from time to time, is on the front burner again thanks to a report from the European Commission. Eucomed has issued a press release welcoming the report whilst noting that it remains "typically neutral in terms of action at ...
Posted in EU Regulatory, Regulation, qmed daily europe | Add Comment »
Wednesday, August 11th, 2010
The European Commission's public consultation on proposed revisions to the In Vitro Diagnostics Directive (98/79/EC) makes reference to "conditional CE marking," reports Clinica (subscription required). And that has generated some buzz in the couloirs at Eucomed and within the larger medtech community. Section 5.1 of the consultation states the following:
For ...
Posted in Regulation, qmed daily europe | 1 Comment »
Tuesday, August 3rd, 2010
Medical device consultancy Emergo Group Inc. has opened a new office in Hamburg, Germany, to meet the needs of a growing European client base. The Hamburg office is the group's fourth in Europe and will greatly expand the firm's ability to serve medical device and IVD manufacturers in Germany, Austria and ...
Posted in Regulation, medtechinsider | Add Comment »
Thursday, July 22nd, 2010
The x73 Manager USB Reference System developed by Wipro Technologies has received IEEE 11073 certification from industry organisation Continua Health Alliance. Wipro is the first healthcare IT services company to achieve this certification for five device classes: blood pressure monitors, pulse oximeters, weighing scales, thermometers and glucometers. The IEEE 11073–based ...
Posted in Regulation, Standards, Wireless technology, medtechinsider | Add Comment »
Wednesday, July 21st, 2010
The entire catalogue of country-specific medical device reimbursement reports published by Factory Reimbursement has been updated. Additionally, reports are now available for two new markets: the Netherlands and Belgium. Formerly known as the Jacoti Reports, the ready-to-download documents offer comprehensive information about medical device reimbursement regulations in seven European Union countries. All ...
Posted in Business News, Regulation | Add Comment »
Monday, July 12th, 2010
Pilgrim Software Inc., a provider of enterprise risk, compliance and quality management (ECQM) software, has announced the global availability of its expanded Regulatory Reporting platform. In addition, the company has introduced the MedDRA adapter, which integrates with its Complaints Management product to simplify adverse event reporting to global ...
Posted in Breaking News, Regulation, medtechinsider | Add Comment »
Wednesday, June 23rd, 2010
"Medical devices are not subject to any regulatory approval; [manufacturers] don't have to prove their effectiveness nor their safety." Would you believe that's what Professor Juergen Windeler, future head of the Institute for Quality and Economic Efficiency in Healthcare (IQWiG), claimed in an article published on 10 June in the German ...
Posted in Business News, Regulation | Add Comment »
Tuesday, May 25th, 2010
Japan's first think tank focused on the medical device industry has been established. The Medical Device Strategy Institute (MDSI) will initiate research and generate dialogue on policy issues of interest. Among its projects is a paper on market trends spanning a quarter century. It is a noteworthy development because Japan’s ...
Posted in Regulation, medtechinsider | Add Comment »
Tuesday, May 4th, 2010
Two of the largest and most influential medical technology trade associations in the world have signed a trans-Atlantic statement on ethical interactions between medtech companies and healthcare professionals (HCPs). John Wilkinson, Chief Executive of Eucomed and Stephen J. Ubl, President and CEO of AdvaMed, which represents the US medtech industry, ...
Posted in Forums, Regulation, medtechinsider | Add Comment »
Monday, March 29th, 2010
Cambridge Consultants, a technology product design and development company, has announced it is to offer a new consultancy service for medical device clinical trials that will save clients time and money through a more effective method of analysing trial data. This news follows the announcement of the US Food and ...
Posted in Regulation, Suppliers | Add Comment »
Tuesday, March 9th, 2010
Medical device manufacturers are required to comply with Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC by 21 March 2010. Despite having made every effort to meet the essential requirements, companies may be surprised to learn that the classification of some of their devices may be challenged, writes René ...
Posted in Regulation, medtechinsider | Add Comment »
Monday, February 1st, 2010
SGS has extended its medical device Notified Body status to include Directive 98/79/EC for in vitro diagnostic (IVD) medical devices. The company’s initial scope of designation as an IVD Directive Notified Body includes all LIST B devices and Self-Test IVD devices. This scope will be further expanded to include all ...
Posted in Industry News, Regulation, medtechinsider | Add Comment »
