Sunrise Labs, an ISO-13485 certified medical device product development firm in Auburn, NH, is pleased to announce its first charity golf tournament, Fore the Cure, raised $10,000 for Joslin Diabetes Center. The Fore the Cure tournament took place on Monday, September 21 at Breakfast Hill Golf Club in Greenland, NH. The $10,000 donation was raised […]
Press Release
enLabel Global Services gold sponsor of 3rd Semi-Annual Medical Device & Diagnostic Labeling Conference
enLabel Global Services is the Gold Sponsor of the 3rd Semi-Annual Medical Device and Diagnostics Labeling Conference, hosted by Q1 Productions, on September 24-25, in San Diego, California. The conference will focus on the importance of maximizing Corporate UDI strategies, optimizing Label Translation & Content Localization strategies, all while streamlining Label Approval Operations and minimizing […]
HPA, FDA & MassMEDIC present webinar to discuss 510(k) quality and the Revised FDA Refuse to Accept Guidance document
Join us for a webinar on Sep 25, 2015 at 12:00 PM EDT. Register now! https://attendee.gotowebinar.com/register/7100566196753420290 Background Presenters: Juan Carlos Serna, Vice President & Brian Young Vice President, Regulatory & Quality Health Policy Associates, Inc. Discussion of how FDA has historically reviewed 510(k)’s for completeness. FDA’s rationale for introducing detailed RTA checklists and the relationship […]
Thermoplastic injection molding: Offering from the design concept to finished molded products
Eagle has now expanded our product capabilities and product offerings to include plastic injection molding. The same level of dedication, meticulousness, and product quality that we have put into our stainless steel tubing will also be applied to the plastic molding. With this added capability, Eagle will now be able to offer from design concept […]
Sunrise Labs, Inc. appoints Eric Soederberg as Company President
AUBURN, NH – Sunrise Labs, Inc. is pleased to announce the appointment of Eric Soederberg as President, effective June 12, 2015. Soederberg, former Vice President and General Manager of Sunrise, is now the Chief Executive of Sunrise Labs. Drew Sunstein, Founder and former President, remains actively involved in the company as Chairman of the Board. […]
MedVenture Technology expands product design and development operations in California
JEFFERSONVILLE, IN – MedVenture Technology Corporation, a medical device design and manufacturing company of minimally invasive surgical and catheter-based devices and a part of Helix Medical, announces the expansion of its product design and development operations in southern California. “We have a significant opportunity to advance MedVenture’s position in the western United States as a […]
Transperfect Medical Device Solutions offers world’s most comprehensive suite of core solutions for device makers
NEW YORK, NY – TransPerfect, the world’s largest provider of language services an content management technology to the medical device industry, today announced the creation of its newest division: TransPerfect Medical Device Solutions. By combining the ISO 13485 and ISO 14971 certified systems and patented risk management processes of TransPerfect’s Crimson Life Sciences division with […]
GW Plastics expands LSR in-house tooling capabilities
BETHEL, VT – GW Plastics is in a select class of injection molders to offer the benefits of in-house mold design-and-build on an international scale. Known globally for their innovation and dedication to excellence, GW Plastics is proud to announce the expansion of in-house Liquid Silicone Rubber (LSR) tooling at their affiliate, GW Silicones. Established […]
GW Plastics leads the way in global medical device contract manufacturing
BETHEL, VT – GW Plastics, a leader in precision injection molding and contract manufacturing to the healthcare market, announced today at the MD&M East 2015 Exposition in New York City the completion of recent expansions at their state-of-the-art Tucson, Arizona and Dongguan, China facilities in response to their rapidly growing medical device assembly business. GW […]
Proven Process client Flowonix Medical Inc. achieves FDA PMA Approval of Prometra II infusion device
MANSFIELD, MA – Proven Process Medical Devices, Inc., a global leader in the design, development, validation, and manufacture of Class II and Class III medical devices, announced today that its client Flowonix Medical Inc. has secured PMA-Supplemental approval from the FDA for its next-generation intrathecal infusion device, the Prometra® II system. Approval of this device, […]
Sunrise Labs announces its sponsorship of the 2015 MD&M East Conference
Sunrise Labs is pleased to announce its sponsorship of the 2015 MD&M East Conference, a three day program focusing on innovations in manufacturing and design for the medical device industry. On Tuesday, June 9 from 10AM to noon, Adam Jacobs, Chief Technology Officer of Sunrise Labs, will moderate the Design Innovation track, From Design to […]
