This is a compilation of the latest news from suppliers in the medical device industry. If you have news you’d like to submit for potential inclusion in this weekly roundup, please send a press release and any related images to [email protected] with the subject line “Supplier Stories.”
[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]
Brentwood Industries has acquired a clean room facility in Tijuana, Mexico that will become its second facility, a medical manufacturing operation, in early 2018. The facility will offer an ISO Class 7 clean room environment and will be used to product custom thermoformed medical packaging.
“We’ve been evaluating expansion into Tijuana for a number of years, particularly considering the large push in the medical industry to source all packing and components as close to the point-of-manufacture as possible,” Andrew Haus, Brentwood’s Medical Product line manager, said in a press release. “This new facility will position Brentwood very favorably in the market, allowing us to continue to offer industry-leading service and value to our customers.”
DuPont Protection Solutions announced that its new Tyvek 40L medical packaging is now available in China. The new offering is lightweight, breathable, and strong. Tyvek 40L is expected to be released worldwide in late 2018.
“Tyvek 40L fills a previously unmet need for a better material to package lightweight, low-risk Class I and IIa devices, especially in emerging Asian markets,” Margaret Pyers, global business leader for DuPont Tyvek Medical and Pharmaceutical Packaging, said in a press release. “We are proud to continue our long tradition of meeting marketplace needs with innovative products that provide trusted protection so people can accomplish bigger things.”
Global photonics company Excelitas Technologies Corp. has secured ISO 13485:2016 certification at its Excelitas Canada facility in Mississauga, Ontario. The certification signifies that the operation has met specific standards for its quality management system and medical device safety.
“This is a really important achievement for the organization, accomplished through the efforts of a dedicated team that manged the process while successfully continuing to operate our growing business at the same time,” Jim Farrell, Excelitas manager in Quality and Environment Management Systems, said in a press release. “We’re very proud of their hard work and the recognition that our quality systems and business processes meet the highest quality standards for our customers’ vital products.”
Prisym ID announced that it will be presenting at the 7th Annual EU Device and Diagnostic Regulation Conference in Brussels, September 25-26, and the American Medical Device Summit in Chicago, October 4-5.
According to a company press release, both Prisym ID presentations will include discussion of EU MDR as well as the company’s PRISYM 360 label life-cycle management product.
[Image courtesy of GERALT/PIXABAY]
Raumedic AG plans to roll out a new digitalized manufacturing execution system that is expected to offer higher transparency and improve the production and quality management operations. The system, powered by software company Guardus Solutions, is slated to be implemented at the company’s production locations in the United States and Germany by 2019.
“The use of digitalized processes will not just open up undreamed of possibilities,” Martin Schenkel, head of operations at Raumedic, said in a press release. “Above all, it will boost the value that we can and will generate for our customers.”
UPM Raflatac is releasing its new line of Raflatac Permanent Medical Device (RPMD) adhesives. The new products can be used for labeling combination products, infusion bags, and sterilization pouches, according to the company. In addition, the products meet the criteria set out by the EU Medical Device Regulation and In Vitro Diagnostics Regulations.
“With our expanded offering for medical device and healthcare applications, including the RPMD adhesive and a selection of FSC and PEFC certified paper faces for pharmaceutical use, we can continue to address the needs of all our customers,” Markku Pietarinen, manager of Business Segments & Pharma, Specials EMEIA at UPM Raflatac, said in a press release. “These innovative solutions are ideal for the combination product market, which is growing quickly as treatment continues to move away from the hospital and out into the field and the home.”