medical device certification News
-
NanoPin Technologies Announce a Strategic Collaboration with Shanghai Reigncom Biotechnology to Bring Novel Infectious Disease Diagnostic Products to the China Market
NanoPin Technologies (New Orleans, Louisiana, USA) announces the establishment of a strategic partnership with Shanghai Reigncom Biotechnology Co., Ltd. (Shanghai, China). NanoPin and Reigncom will work together to commercialize NanoPin’s high-sensitivity and high-specificity infectious disease detection technology on Reigncom's RZ-500 ultra-high performance liquid chromatography tandem ...
-
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. ...
-
BSI extends healthcare rReach with Eurocat acquisition
BSI, the global standards and assessment body, has acquired German healthcare certification and testing business, EUROCAT. This development significantly enhances BSI’s ability to service the medical device market globally.EUROCAT is an established Notified Body offering healthcare systems and product certification. The company has a significant presence in Germany - the third largest medical ...
-
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
-
Exsomed Corporation Announces Completion of MDSAP Certification and ISO 13485:2016 Audit With Zero Findings
ExsoMed Corporation, a privately held U.S.-based medical device company providing orthopaedic surgeons with innovative solutions in hand surgery, announced that it has successfully completed Medical Device Single Audit Program (MDSAP) certification and ISO 13485:2016 audits, with no open findings. MDSAP is a program that allows for one regulatory audit of a medical device manufacturer’s ...
-
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 ...
-
WilMarc Certified by the Women’s Business Enterprise National Council
WilMarc, a business specializing in PVC Free manufacturing of medical devices, is proud to announce national certification as Women’s Business Enterprise by the Women’s Business Enterprise Council – West, a regional certifying partner of the Women’s Business Enterprise National Council (WBENC). “WilMarc is proud of its heritage as a woman-owned business,” said ...
-
BSI launches new CE-Dedicated FastTrack Program at RAPS Conference
BSI, a world-class Notified Body providing regulatory and quality management reviews and product certification for medical devices, today announced the launch of CE-Dedicated FastTrack. This new CE marking program is designed to help medical device manufacturers get their products quickly and safely to European markets. BSI will debut the program at the 2009 Regulatory Affairs Professionals ...
-
Infection transmission prevention and control of Coronavirus (COVID-19) made possible through Genano Air Decontamination Units
Infection control procedures including work practices, protocols and controls, environmental hygiene, air filtration and appropriate use of Personal Protective Equipment (PPE) are all necessary to prevent infections from spreading during healthcare service delivery. But in the case of the recent Coronavirus (COVID-19) outbreak early detection and isolation of potentially infectious patients is ...
-
Asensus Surgical, Inc. Reports Operating and Financial Results for the Fourth Quarter and Full Year 2020
Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced its operating and financial results for the fourth quarter and full-year 2020. Recent Highlights Senhance Surgical System received expanded 510(k) clearance for general ...
Need help finding the right suppliers? Try XPRT Sourcing. Let the XPRTs do the work for you