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Iso 13485 Articles & Analysis
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It spreads primarily through skin-to-skin contact, and it is treatable but not curable.Manufactured under ISO 13485 standards, this new portfolio of antibodies can ensure exceptional quality and reproducibility. ...
Introduction The pharmaceutical industry demands absolute precision, reliability, and safety throughout every stage of production. Whether manufacturing life-saving medicines or performing sensitive research, facilities must maintain strict control over environmental conditions. One often overlooked but essential component is gas analysis. Gases such as oxygen, nitrogen, and carbon dioxide play ...
MedSource Labs Moves the Needle in the Peripheral Safety IV Market With the announcement of ClearSafe Comfort® and TrueSafe Comfort® Blood Control IV Catheters with groundbreaking active check valve ...
Produced under stringent quality control, with selected manufacturing requirements from ISO 13485 and GMP Annex 1 certification for production facilities, CELLINK is providing users with a batch-to-batch material consistency vital for translation to clinics. ...
ByCELLINK
In addition to the FDA approval, FARCO-PHARMA has been meeting all domestic and international market requirements through our production activities at GMP-certified production sites and the certification of our quality assurance system and medical devices in accordance with EN ISO 9001 and EN ISO 13485 in compliance with European law for over 20 ...
Real time tracking and reporting sets a new standard for monitoring adherence and potentially improving patient outcomes. Portal Instruments is ISO 13485:2016 ...
In addition to clinical applications, pharmaceutical companies rely on VIDA’s ISO 13485-certified core lab processes to facilitate research on drug therapies for people with these life-changing conditions. ...
CardioWise, Inc., is pleased to announce that Perry Johnson Registrars, Incorporated has audited the CardioWise Quality Management System (QMS) and determined CardioWise is in conformance with ISO 13485:2016. Perry Johnson Registrars Certificate C2022-02910 was issued July 16, 2022, and represents the first step in the process of obtaining a CE mark and Medical ...
Senstech AG was founded in 1984 by Rolf Wolfensberger. The ISO 9001 and ISO 13485 certified company is based in Fehraltorf near Zurich and employs 10 people. ...
The 10,000 square foot operation was recently certified by the designated European Notified Body, BSI, to International Standards Organization (ISO) 13485:2016. “Expansion and ISO certification of our California headquarters will enable us to add additional personnel as we prepare to submit the Altius System Pre-Market Approval application ...
Recent Highlights Successfully completed 9 VenoValve surgeries and 16 sites currently activated in the Company’s SAVVE U.S. pivotal trial for the VenoValve; Presented positive long-term VenoValve first-in-human data at the 34th Annual Meeting of the American Venous Forum; Announced publication of one-year VenoValve data in the peer-reviewed journal,Vascular and Endovascular Surgery;and ...
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. ...
Having served Fortune 500 companies since 1982, Quest offers a robust suite of new services and solutions throughout its three business units: OEM Services, IT Services and Technology Solutions. Quest is ISO 9001, 13485, 14001, and ANSI/ESD S20.20 Certified with over 30 operation centers ...
Rule is an ASQ Six Sigma Green Belt and has training as an ISO 13485 Auditor. He has additional qualifications in Project and Program Management as well as FDA Clinical Trial oversight. ...
They offer a value-added approach to high-precision manufacturing with specialties in CNC milling, turning and cutter grinding. The company has achieved ISO 13485:2016 certification and is an FDA registered facility. In addition to their facilities in Kentwood, Michigan, Autocam Medical has operations in Murfreesboro, Tennessee; Plymouth, Massachusetts; Suzhou, ...
Our fully owned 20,000 square foot research and production facility achieved the valuable ISO 13485 certification in February of 2021 and provides a highly efficient center for both R&D and production. ...
BrainScope has received seven FDA clearances and ISO 13485 Certification. It has 26 peer-reviewed publications on its technology. ...
They offer a value-added approach to high-precision manufacturing with specialties in CNC milling, turning and cutter grinding. The company has achieved ISO 13485:2016 certification and is an FDA registered facility. In addition to their facilities in Kentwood, Michigan, Autocam Medical has operations in Murfreesboro, Tennessee; Plymouth, Massachusetts; Suzhou, ...
We are happy to announce that Hyalex Orthopaedics has received ISO 13485:2016 certification for Medical Device and Quality Management Systems. ...
They offer a value-added approach to high-precision manufacturing with specialties in CNC milling, turning and cutter grinding. The company has achieved ISO 13485:2016 certification and is an FDA registered facility. In addition to their facilities in Kentwood, Michigan, Autocam Medical has operations in Murfreesboro, Tennessee; Plymouth, Massachusetts; Suzhou, ...