Month: November 2015

In the mean time, following the partial agreement in June 19, the European Council has made some technical corrections to their agreed texts.

The Council Workgroup as well as the Parliaments rapporteurs and shadow rapporteurs have started to prepare for their positions in the trilogue negotiations.

Some of the aspects in the debate are relatively new, such as the grandfathering options and the selective assessment schemes for products already on the EU market.

The sessions started mid-October, with 3 meetings conducted and 3 scheduled at this stage: two in November and one in December. Significant preparation has gone, and will go into each of these sessions, the first of which concentrated on chapter I and Annexes I-V of both MDR and IVDR.

Luxembourg, the current chair of the European Union, is striving towards finalization. The further key issues prone to compromises are the following:

• clinical studies versus literature
• scrutiny process
• notified bodies and their supervisory structures
• reprocessing of single use device

Assuming a positive scenario, legislation may be finished towards the middle of 2016.

www.zdravo-expo.ru

As part of the Company’s customer experience initiative, LOK Network has vowed to provide useful information to Manufacturers on a quarterly basis. 

“Our customers demand specific target marketing resources to reach distributors and end-users. And it was a natural extension of our business to provide them in an easy to read format that will focus to supply sufficient details on each subject”.

Featuring articles specially designed for Medical Device Manufacturers such as The Director Interview, featuring interview with CEO manufacturers.

The success of our customers is based on information, and we will make sure that New Regulatory, Sales Strategy, Customer Care Best Practices and Market Intel information are present in every edition.

Don’t wait to register, it is completely free and requires simply 4 clicks of your time!

The new December issue will include:

• Regulatory in India
• Manufactures sales strategy
• Customer support best practices
• Interview with the CEO of Tortle
• Discovering Canada

“Our online visitors will now experience a more vibrant and seamless view of the whole LOK Network and its deep online resources in one physical location,” says Sebastien Cloutier, International Marketing Director for LOK Network. “In the same way that the creation of all the LOK individual websites per Country will streamlined access to our very rich cultural regional specific content, making virtual visits to our Network more informative than ever.”

“This new design was created specifically for our online audience of both general visitors and professionals,” says International Sales Director Elena Andreeva. “Providing a better visual with high-quality videos, news, and detailed information on services that will be constantly updated, the Website will help make LOK Network’s extensive resources more attractive and accessible to a global audience of the Medical world.”

It also allows Health Canada to react more quickly and more adequately when a product is causing a serious health risk. The government can now require a recall or impose a label change to the company. Along with these measures, new fines and penalties have been created to suit more accurately the seriousness of the violation. More information on http://www.hc-sc.gc.ca/dhp-mps/legislation/unsafedrugs-droguesdangereuses-faq-eng.php.