What you missed – EU MDR update; FDA collaboration

What you missed – EU MDR update; FDA collaboration

EU MDR implementation up for delay; Contract manufacturer expands; Dassault Systèmes, FDA collaborate; A torso twists; Learn about surface finishes

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I’m off for a few days of R&R but wanted to quickly recap some of the current medical design news, contract manufacturing expansions, the conversation on an extension of the EU MDR deadline that's fast approaching. Also, the August issue of Today’s Medical Developments is in the mail (hint: the digital edition is available to read today!)

 

http://cirtecmed.com

Cirtec Medical to open 30,000 sq. ft. manufacturing facility in Costa Rica


Officials from Cirtec Medical Corp., a strategic outsourcing partner for complex medical devices, including active implantables and minimally invasive devices, announced construction began on a 30,000ft2 manufacturing facility in the Coyol free zone, located in Alajuela, Costa Rica.

The facility, which is expected to be fully operational by the end of the year, will be the company’s first venture into Latin America and is a result of Cirtec’s growth and the increased demand for high volume, cost-effective manufacturing. The facility will deliver expanded value-added manufacturing services such as neurostimulation leads, coil winding, and finished device assembly and packaging. The facility will include Class 7 and Class 8 cleanrooms and office space with additional room for future expansion. The operation will require hiring at least 40 local employees for the facility within the first year of operation.

 

Statement by the United States to the committee on technical barriers to trade – European Union – Medical Device Regulation (MDR) and in vitro Diagnostic Medical Devices Regulation (IVDR)

In a July 24, 2019 statement by the United States to the World Trade Organization Committee on Technical Barriers to Trade, officials urged “the EU to delay implementation by three years to allow for U.S. exporters to adapt to the new requirements,” stating as one concern that MDR/IVDR implementation is behind schedule. Read the full statement here.

Learn more about the EU MDR deadline and let us know how it’s impacting your operations?

 

Torso simulator advancing medical innovations

A simulator mimics mechanical behavior of the torso and the engineers who created it hope it leads to innovations in the design of medical back supports.

 

Dassault Systèmes, FDA collaborate to accelerate medical devices

5-year extension of collaborative research agreement aims to spur medical device innovation by enabling innovative, new product designs.

 

Have you seen? Surface preparation for proper adhesion webinar

Don't miss this free webinar recording covering perparation of surfaces for proper adhesion, presented by BTG Labs and its founder Dr. Giles Dillingham.