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Contract Manufacturing and Packaging Services » ISO 13485 Certified

Pacific Plastics & Engineering Opens New Class 7 Clean Room


Released by Pacific Plastics & Engineering



Excerpt: Pacific Plastics & Engineering has added another stand-alone Class 7 (10,000) clean room with automated lines. The production line now includes two Class 7 clean rooms and five Class 8 (100,000) clean room... continue

NeedleTech Products Expands Operations With Relocation


Released by NeedleTech Products, Inc.



Excerpt: NeedleTech Products Inc. has announced that, as part of a recent expansion, the company will be moving to a 73,000-square-foot facility in a nearby industrial park in North Attleboro, Mass. The new facility in... continue

ATEK Plastics Receives ISO 13485 Certification


Released by ATEK Plastics



Excerpt: ATEK Plastics, a full-service precision injection molding solutions provider, recently went through a certification audit the week of April 26 -30 and is now certified to the medical standards of ISO 13485:200... continue

Global Medical Device Company Recognizes Omni Components Corp. for Excellence as Supplier of the Year


Released by Omni Components Corp



Excerpt: Omni Components Corp. is pleased to announce that Orthofix International has selected Omni as its 2009 “Supplier of the Year” for Spinal Implant Products. The award is based on over... continue

Summit Corporate Services secures ISO 13485 and 9001 Certification


Released by Summit Corporate Services



Excerpt: Summit Corporate Services, a leading provider of customer service, inventory management and order fulfillment solutions for the life-science industry, announces its 13485:2003 and 9001:2008 certifications for... continue

SMC Ltd. Chosen As 2009 Business Of The Year


Released by SMC Ltd.



Excerpt: SMC Ltd., a medical device contract manufacturer with locations in Somerset and Amery Wisconsin along with California, Massachusetts, Ohio, and India, has been chosen to receive the 2009 business of the year a... continue

Tegra Medical Adds Injection & Insert Molding


Released by Tegra Medical



Excerpt: Tegra Medical has added injection and insert molding services to its Dartmouth, Mass., site. Because many metal components produced by Tegra are subsequently assembled with plastic components, a new 44-ton Arburg AL... continue

Ethox Surgi-Cuf Soft Offered at New Low Price


Released by Ethox International



Excerpt: Ethox International’s Surgi-Cuf SOFT family of disposable blood pressure cuffs are now available at a new low price. Patients will experience the ultimate comfort of the soft, woven fabric during... continue

Veridiam Medical Introduces New Spin Welding Capabilities for Joining Plastics to Metals


Released by Veridiam Medical



Excerpt: Veridiam Medical, a provider of assemblies, machined parts and metal tubular components specifically engineered to meet the demanding requirements of medical device manufacturers, has introduced new Spin Welding cap... continue

Maxon Medical Receives ISO 13485 Certification


Released by Maxon Precision Motors, Inc.



Excerpt: The drive specialist has met the requirements of a key medical standard  and is strengthening its business in microdrives  for the medical industry. Maxon Motor’s Maxon Medical business unit, which s... continue

Helix Medical Announces Certifications for Cleanrooms in California and China


Released by Helix Medical, LLC



Excerpt: Helix Medical announced today ISO Class 7 & 8 cleanroom certification, in accordance with ISO 14644, for their Carpinteria, California operations.  In add... continue

IBS to Expand Pilot Production of Pre-filled Syringes to One Million Units


Released by Integrated BioSciences



Excerpt: Integrated BioSciences, Inc. (IBS) announces that its parent company, Unilife Medical Solutions, has signed an exclusive license agreement with sanofi-aventis, one of the world’s leading pharmaceutical compani... continue

Helix Medical Expands Manufacturing Capabilities


Released by Helix Medical, LLC



Excerpt: Helix Medical, LLC announces expanded capabilities with new manufacturing operations in Baldwin Park, CA ; Gloucester, MA ; and Shenzhen, China . Helix Medical no... continue

PEDI Produces Pharma Diagnostic Tray Through Film Insert Molding


Released by PEDI - Plastics Engineering and Development, Inc.



Excerpt: PEDI is molding a 384-well tray for biological testing.  Human cells and pharmaceutical drugs are placed in the wells of the tray for research and development.  To manufacture the tray, plastic is molded o... continue

Raven Introduces ProAMP


Released by Raven Labs



Excerpt: Raven introduces ProAMP, a self-contained biological indicator for use with industrial steam sterilization between 118-135°C. ProAMP is small in size (26.5mm x 6.5mm) so that it can be used... continue

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Medinvents Offers Spirotome Biopsy System


Released by Medinvents



Excerpt: The Spirotome is a manual, large-core biopsy system for soft tissues based on a helix and cutting cannula.  Various diameters, lengths and formats are available for use in many organs.  The device is eithe... continue

Freudenberg-NOK General Partnership (FNGP) Acquires Assets of APEC


Released by APEC



Excerpt: FNGP acquired APEC to expand their plastic and silicone molding capabilities within the medical market.... continue

PEDI Receives California FDB Device Manufacturing License


Released by PEDI - Plastics Engineering and Development, Inc.



Excerpt: PEDI announces certification by the California Food & Drug Branch (FDB) to manufacture medical devices.  The FDB, partner with the... continue

Tapemark Expands Snap! Product Family


Released by Tapemark



Excerpt: Tapemark is pleased to announce the newest members of its Snap! product family. Now available are the Snapplicator, which adds a convenient applicator for &ld... continue

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