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64 Total results for product and free and sample content found

Medtech Insight

EU Regulatory Roundup November 2018

By Amanda Maxwell 05 Dec 2018

The medtech sector was already quite overwhelmed with the new EU regulations and Brexit uncertainties. Now add into the mix the impact of the global journalistic Implant Files investigation.

Topic Brexit Medtech

Medtech Insight

Commissioner Says EU MDR/IVDR Implementation 'On Track,' But Fails To Convince Parliament

By Amanda Maxwell 31 Oct 2018

Elżbieta Bieńkowska, a European Commissioner,  is "realistic and confident" when it comes to the implementation of the new EU medtech regulations. She says everything is going to plan. But that is not what members of the European Parliament are hearing.

Topic Medtech

Medtech Insight

US FDA Shelves Proposal To Mandate Home-Use Device E-Labeling

By David Filmore 18 Oct 2018

A controversial 2016 proposed rule that would have required manufacturers of many class II and class III home-use devices to electronically submit device labeling information to US FDA will not be finalized, the agency affirmed in the Oct. 17 HHS Unified Agenda document. The agency also signaled plans to imminently finalize a broad device classification rule, and other updates.

Topic Medtech

Medtech Insight

TCT 2018: Next-Gen Stents, Key Insights From Leading Experts

By Marion Webb 26 Sep 2018

The Transcatheter Cardiovascular Therapeutics meeting held in San Diego featured late-breaking trials of new stent technologiesincluding TALENT, BIONYX, BIOFLOW-V, SORT-OUT IX, LEADERS FREE II and ReCre8.

Topic Medtech

Medtech Insight

First EU Notified Body Designations Could Come Earlier Than Expected, But Caution Advised

By Amanda Maxwell 26 Sep 2018

There's been progress toward designating notified bodies against the EU's medtech regulations, but the developments need to be scrutinized so that the sector preserves a sense of reality about capacity issues, MedTech Europe's Oliver Bisazza says.

Topic Medtech

Medtech Insight

Critical EU Authorities Meeting Next Week Could Be Make-Or-Break For Many Medtech Companies

By Sue Darcey 21 Sep 2018

The EU medtech industry is trying to put the brakes on the full application of the new Medical Devices and IVD Regulation as a logjam looms. What is it doing to succeed? And why is time running out?

Topic Medtech

Medtech Insight

Top Medtech Lobbyist Doubts Legislative Repercussions Of New Netflix Documentary

By Ferdous Al-Faruque 30 Aug 2018

AdvaMed's top lobbyist says a new documentary critical of the medical device industry and US FDA's device review pathways is unlikely to result in Congressional action. However, the group is talking to members on Capitol Hill to make sure they fully understand the context within which devices are reviewed and marketed.

Topic FDA Medtech

Medtech Insight

Mock Audits: Has Ambiguity In EU Led To Unfair Advantage?

By Amanda Maxwell 22 Aug 2018

There's been confusion and conflicting opinions about notified bodies conducting mock audits on companies' documentation to prove conformity with the impending EU Medical Device and IVD Regulations. Has the lack of clarity led to different and unfair practices? Does it matter?

Topic Medtech

Medtech Insight

Canada Consults On Mandatory Reporting Of Device Incidents By Hospitals

By Vibha Sharma 22 Aug 2018

The Canadian government has made it mandatory for hospitals to report medical device incidents and serious adverse reactions in their control irrespective of where these incidents originate.

Topic Medtech

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