Autocam Medical facility certified to ISO 13485:2016

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

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

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

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

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

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

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

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

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

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

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

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

Dutch Mellon Medical unveils major innovation in surgical suture technology: Single-handed suturing using the Switch

Mellon Medical is unveiling a patented ground-breaking global innovation in suturing technology. The company has developed a platform technology for suturing with a single hand. The Switch, a disposable precision-suturing instrument, enables surgeons to suture tubular and layered structures about twice as fast as the conventional technique. The technology is expected to reduce the risk

Medical Murray adds clean room space in two facilities

Medical Murray, a device development and contract manufacturing company with ISO 13485 certification and FDA registration, has expanded clean room capabilities in their Illinois manufacturing facility and North Carolina location. The additions come less than a year after Medical Murray purchased their Lake Zurich, Ill., 44,000 square-foot manufacturing facility, and built a larger 10,000 square-foot

RTI Surgical receives regulatory clearances, expands distribution of nanOss Bioactive in Australia and Europe

RTI Surgical, a global surgical implant company, announced it has recently received regulatory clearance from the Australian Therapeutic Goods Administration for nanOss Bioactive bone void filler in Australia. The company also announced it has received CE mark from BSI for nanOss Bioactive Loaded bone void filler and nanOss Bioactive 3D bone void filler in Europe.