Raumedic recently gained ISO-standard 15378:2016-3 certification for its packaging solutions in the pharmaceutical industry. ISO standard 15378 requirements are outlined for primary pharmaceutical packaging producers. Because packaging comes into contact with pharmaceutical, packaging has to be manufactured carefully. “Monitored processes and production in the clean room help us keep contamination risks to a minimum,” Winifried
Raumedic receives ISO quality-standard certification for pharmaceutical packaging
February 21, 2018 By Leave a Comment
Mack Molding systematizes ISO 9001 and 13485 revisions
February 7, 2018 By Leave a Comment
Mack Molding recently announced that is has started the process of systematizing ISO 9001:2015 and ISO 13485:2016 fifth and third revisions for medical devices. The company plans to train internal auditors to help assure that Mack Molding is ready to be certified after audits that are scheduled for July. “When we first implemented ISO 9001
NSF International appoints new executive director of medical device certification and training
January 22, 2018 By Leave a Comment
NSF International has appointed FDA veteran Robert Ruff to the role of executive director of medical device certification and training. Ruff will offer expert training and certification services to NSF International’s medical device industry clients. He will be responsible for managing key sectors of the company’s medical device business. “Rob brings the utmost integrity and
Autocam Medical facility certified to ISO 13485:2016
October 10, 2017 By Leave a Comment
Autocam Medical (Kentwood, Mich.) announced that its Plymouth, Mass. facility was recently certified to ISO 13485:2016. The surgical implants, instruments and related products manufacturer showed that its quality system was effectively implemented and maintained in order to be ISO 13485 certified. “This recertification indicates our continued investment in a quality management system which ensures process control, accurate
RJG Technologies gets PAA VQ\SET recognition and ISO certification
July 13, 2017 By Leave a Comment
RJG Technologies has announced that it has received ISO 9001:2015 certification and PAA\VQ-SET center recognition. The PAA\VQ-SET center recognition allows RJG to enroll people in the level 3 diploma for polymer processing operations that is part of its apprenticeship. “This center recognition will enable RJG to manage the enrollment of apprentices for the qualification that
Ametek Land secures CSA certification for NIR Borescope
January 24, 2017 By Leave a Comment
Ametek Land, the leading industrial infrared non-contact temperature measurement specialist, has secured CSA certification for its Near Infrared Borescope (NIR-B) 3XR for use in hazardous locations in the U.S. and Canada. The NIR-B 3XR, which was launched for the industrial gas sector in 2016, delivers continuous reformer tube wall temperature (TWT) measurement and furnace optimization
Qosina receives ISO-13485 certification
November 23, 2016 By Leave a Comment
Qosina is pleased to announce that we have received ISO 13485 Certification, a globally recognized standard that specifies the requirements for a quality management system that can be used by organizations providing medical devices, components and delivery of related services. This certification allows Qosina to comply with the ever-changing needs of our customers while meeting
TenAsys introduces 64-bit extended memory use for the INtime real-time operating system platform
November 18, 2016 By Leave a Comment
TenAsys extends its advanced consolidation solutions for multicore PCs with full access to available system memory and cutting edge programming language support. Newly released version 6.2 of the INtime real-time operating system enables memory extension technology providing each process access to 4 GB of physical memory, regardless of the number of processes and cores used
SINBON Electronics is the first company in Asia to achieve accreditation from MedAccred
November 18, 2016 By Leave a Comment
The SINBON Electronics site in Jiangyin, China has become the first in Asia to gain an accreditation from MedAccred after meeting all the requirements for cable and wire harness assemblies. During a challenging four-day audit, the SINBON team in Jiangyin were successfully able to demonstrate that their manufacturing processes are fully compliant with MedAccred’s Audit
Exact Imaging receives ISO 13485 quality management system certification
November 14, 2016 By Leave a Comment
Exact Imaging, a developer in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance of the prostate, announced that its quality management system has been certified as complying with the requirements of ISO 13485:2003 and EN ISO 13485:2012. The standard represents the requirements for a comprehensive quality management system for the design and manufacture of
CTL Medical Corporation achieves ISO 13485, CE certification
October 25, 2016 By Leave a Comment
CTL Medical Corporation, a Dallas-based medical device manufacturing and service company, announced that it has applied for and been granted both ISO 13485 and CE Mark certifications. The International Organization for Standardization, based in Geneva, Switzerland, is an independent, non-governmental organization covering industry standards in a wide range of industries from technology to food safety,
SDP/SI solves high-speed application challenge
October 21, 2016 By Leave a Comment
Each component in a design impacts its future direction. Make sure your choices are the best to achieve your desired objective. In today’s high-speed and lightweight applications plastic components succeed where metal formerly served. Cam Followers using plastic, high-load capacity composite rollers are a maintenance-free, clean and quiet running alternative to traditional metal designs. Established
MedAccred’s first accreditations for plastics injection molding awarded to MTD Micro Molding and BMP Medical
October 13, 2016 By Leave a Comment
In early 2016, MTD Micro Molding and BMP Medical volunteered to facilitate the pilot process for MedAccred’s new AC8160 Audit Criteria for Injection Molding. Both companies participated in the challenging and highly technical critical process pilot audits. As active members of the MedAccred Plastics Task Group, which is comprised of technical experts from a number
MTD Micro Molding is the first micro injection molding company to receive MedAccred Certification
October 13, 2016 By Leave a Comment
MTD Micro Molding, a long-time leader in micro-injection molding for the medical device industry, is the first micromolding company in the world to achieve MedAccred Certification. MedAccred, administered by Performance Review Institute (PRI), is an industry managed, consensus-driven approach to ensuring critical manufacturing process quality throughout the medical device supply chain. MedAccred establishes stringent industry
Datwyler invests more than $102 million in new U.S. plant
October 13, 2016 By Leave a Comment
Datwyler is investing in further expanding its production capacity for high-quality elastomer components for injectable drug delivery systems. The company is planning to spend more than $102 million USD on building a new plant in Delaware, with construction work likely to get under way before the end of 2016. Production is scheduled to start in
