ISO 13485 News
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Scion Medical Technologies Receives ISO 13485 Certification
Newton, MA– Scion Medical Limited was awarded ISO 13485 certification both for its China manufacturing facility in Taizhou, China and for its US subsidiary, Scion Medical Technologies LLC. ISO 13485 is an internationally recognized quality standard for medical devices. ISO 13485 represents the requirements for a comprehensive quality management system for the design and manufacture of ...
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Transluminal Technologies Achieves ISO 13485 Registration
Transluminal Technologies has been assessed and approved by BSI Group America against the provisions of ISO 13485:2003. Successful registration assures the firm’s quality management systems comply with requirements established by the International Organization for Standardization (ISO). ISO 13485:2003 is an internationally recognized quality standard specifically focused on the medical ...
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We are now certified by DEKRA Certification GmbH
February 21, 2014 – The management system of Inkutec was audited by DEKRA Certification GmbH. We are now certified according to EN ISO 13485:2012 as well as ISO ...
By Inkutec GmbH
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ISO 13485 Audit Passed 2022
Cryptych P/L, Vestech’s sister company, recently passed its annual ISO 13485 audit, carried out by notified body BSi. This pass was a significant milestone and the fact that there were no non-conformances is an outstanding achievement by the whole of the Vestech team. Vestech’s experience with maintaining ISO13485 (for CE Marking and Australian compliance), as well as CFR21 for FDA ...
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MindChild Medical, Inc. Announces ISO 13485 Approval
(BusinessWire, North Andover, Massachusetts), MindChild Medical, Inc. today announced that it has received ISO 13485:2003 certification for the design, development and manufacturing of its MERIDIAN family of non-invasive Fetal Monitors1,2,3,4 . ISO 13485:2003 certification precedes European pre-market submission of a Technical File submission5 , enabling European commercialization of the MERIDAN ...
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Hyalex Receives ISO 13485 Certification
We are happy to announce that Hyalex Orthopaedics has received ISO 13485:2016 certification for Medical Device and Quality Management Systems. This certification is a regulatory requirement and international standard outlining requirements for a medical device quality management system. It brings Hyalex one step closer to the clinic and patients who may benefit from the HYALEX Cartilage System. ...
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Commitment to Access, Quality and Growth through Innovation
Dynacare Launches JOINTstat® Testing in Canada Augurex is pleased to announce the launch of JOINTstat (14-3-3?) testing services through Dynacare, one of Canada’s largest and most established health solution companies with a dedicated mission to support healthy lives with commitment and care. This arrangement will make JOINTstat testing accessible to more patients and physicians ...
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SteriLux has received ISO 13485:2016 certification
We are excited to announce that SteriLux has received ISO 13485:2016 certification for Medical Device and Quality Management Systems from Lloyd’s Register. This ISO certification indicates that the company’s quality management system meets the most current regulatory requirements specific to the medical device industry. “We are very proud to have received this certification ...
By SteriLux SA
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Proa Medical receives Device Manufacturing License from the State of California
Proa Medical, Inc. was granted a Device Manufacturing License by the Department of Public Health Food and Drug Branch of the State of California. "Proa Medical has a high commitment to quality and has created a culture of quality that reaches all aspects of its operations," said Proa Chief Operating Officer Afshin Nadershahi. "Our quality system an important asset that we are able to leverage in ...
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Colibri Heart Valve Receives ISO 13485 and EN ISO 13485 Certification
Colibri Heart Valve LLC, a privately held emerging medical device company focused on structural heart applications, announced today that it has received certification from DEKRA Certification B.V. that the company complies with the European requirements of ISO 13485 and EN ISO 13485 for a comprehensive quality management system for the design and manufacture of the company’s pre-packaged, ...
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Fibralign receives ISO 13485:2016 upgrade certification
Fibralign received Certification Notification on January 21, 2019 from DEKRA Certification B. V. that the Company’s management system meets the requirements of EN ISO 13486:2016. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry. ISO 13485:2016 is designed to respond to the latest quality management ...
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Biomatlante receives MDSAP Accreditation
Biomatlante, a world leader in synthetic bone regeneration technologies, is pleased to announce the obtention of the MDSAP* accreditation on the new ISO 13485:2016 Certificate. The Medical Device Single Audit Program (MDSAP) is an international program for assessing the quality management systems of medical device manufacturers who market their products in Australia, Brazil, Canada, Japan and/or ...
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Fibralign receives ISO 13485:2012 Certification
Fibralign received Certification Notification on February 18, 2018 from notifying body DEKRA Certification B. V. that it’s management system meets the requirements of EN ISO 13486:2016:2012 + AC:2012. The scope of the certification is for the design, development, manufacture and distribution of porcine collagen scaffold implants used for soft tissue repair and support, ...
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Oncomfort receives ISO 13485:2016 certification
ncomfort, the leader in Digital Sedation™, a digital therapy to relieve patient anxiety and pain, today announces that it has obtained the ISO 13485:2016 certification by certification company DARE!! Services. This certification confirms that Oncomfort manages the design, manufacturing and distribution of its Digital Sedation™ medical device and its Sedakit™, in its quality ...
By Oncomfort
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dBMEDx™ , Inc. Announces CE Mark for BBS Revolution™ Bladder Scanner
dBMEDx, Inc., a privately-held, wireless medical device company, announced today that it has received the CE Mark for the BBS Revolution™, a next generation bladder scanner which offers, for the first time, fully automated bladder detection and unparalleled ease of use, speed and accuracy for the non-invasive measurement of bladder volume. This product is currently FDA cleared and is being ...
By dBMEDx
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FARCO-PHARMA initiates sales in the U.S.
The U.S. Food and Drug Administration recently completed its regulatory inspection of the production site in Berlin and issued FARCO-PHARMA approval for the marketing of a sterile lubricant in disposable syringes in the United States. FARCO-PHARMA has been producing and selling the sterile catheter lubricant under the brand name GLYDO® on the U.S. market since October 2014. Medicinal ...
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Senstech AG becomes part of the IST Group
Senstech sensors can be found in a variety of applications in the medical field, such as infusion or insulin pumps, in cardiotocography or in devices for eye surgery. Other important areas of application are textile machinery, mechanical engineering, the watch industry, industrial pressure measurement technology, and applications for cars. In addition to OEM sensor solutions the company also ...
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BioXtreme Announces CE Marking
BioXtreme is proud to announce that, following our ISO-13485 certification from the Israeli Standards Institution (www.sii.org.il), it has received its CE Marking, based on self declaration. The CE Marking is intended for deXtreme, our upper limb neurorehabiliatation robotic device, meant to treat stroke and other TBI patients with our novel Error Enhancement technology. By this CE Marking we ...
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Learn About Computrol’s Rapid Prototyping Capability at APEX
Computrol, Inc., a world-class provider of mid- to low-volume, high-mix electronic manufacturing services to OEMs, will exhibit in Booth #1640 at the 2020 IPC APEX EXPO, scheduled to take place Feb. 4-6, 2020 at the San Diego Convention Center in California. The company has continuously upgraded its state-of-the-art manufacturing facilities over the past three years. The company most recently ...
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Rapid point-of-care testing using screen-printed electrodes from Metrohm DropSens
Point-of-care (POC) testing with screen-printed electrodes allows rapid testing of populations for viral outbreaks – at affordable costs, without the need for trained specialists and/or complicated equipment. A free white paper from Metrohm puts a focus on the viability of electrochemical testing citing a number of recent studies on the possibility of POC testing for viruses of ...
By Metrohm AG
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