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Certification News

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46-60 of 196 results
Persistent Systems obtains ISO 13485:2003 certification
By MDBR Staff Writer
Persistent Systems, a global company specializing in software product and technology services, has obtained ISO 13485:2003 certification from DNV.
Certification > News
Solos Endoscopy passes Stage 2 of ISO 13485:2003 audit with TUV SUD America
By MDBR Staff Writer
US-based Solos Endoscopy has successfully passed Stage 2 of ISO 13485:2003 audit with TUV SUD America.
Certification > News
RTI Surgical’s Alachua facility passes FDA inspection
By MDBR Staff Writer
RTI Surgical, provider of orthopedic and other biologic implants, has received a positive feedback from the US Food and Drug Administration (FDA), following its two- day inspection at its Alachua processing facility in Florida.
Certification > News
Monarch Medical achieves ISO 13485:2003 certification
By MDBR Staff Writer
Monarch Medical Technologies, a US-based medical technology company, has obtained ISO 13485:2003 certification for its quality management system from the independent certifying body, Nemko.
Certification > News
Preventice receives ISO 13485: 2003 certification
By MDBR Staff Writer
Preventice, a developer of mobile health applications and remote monitoring systems, has received ISO 13485: 2003 certification for its quality management system.
Certification > News
Aggredyne achieves ISO 13485 certification for medical device
By MDBR Staff Writer
US-based Aggredyne has obtained ISO 13485 certification for implementing rigorous quality control program related to the manufacture of the AggreGuide family of platelet function analyzers.
Certification > News
Solos Endoscopy to obtain ISO 13485 certification for quality management
By MDBR Staff Writer
TUV SUD America, a testing, inspection and certification organization, has completed its stage 2 ISO 13485 audit with Solos Endoscopy on August 16, 2013.
Certification > News
Nelson Laboratories secures European Union's GMP Compliance Certificate
By MDBR Staff Writer
Nelson Laboratories, a provider of full, life-cycle microbiology testing services, has received the European Union's Good Manufacturing Practice (GMP) Compliance Certificate for its laboratory’s facilities and processes after the inspection was done by Medicines and Healthcare products Regulatory Agency (MHRA).
Certification > News
Convergent Dental secures FDA clearance for CO2 laser system
By MDBR Staff Writer
Convergent Dental has received the US Food and Drug Administration (FDA) clearance for its Solea, a CO2 laser system for ablation of hard tissue for caries removal and cavity preparation.
Certification > News
Integra LifeSciences obtains 510(k) clearance for reverse shoulder system
By MDBR Staff Writer
Integra LifeSciences has received US regulatory clearance to market its Integra Titan Reverse Shoulder System, which offers greater flexibility for shoulder replacement surgery.
Certification > News
EnteroMedics seeks premarket approval for VBLOC therapy in obesity treatment
By MDBR Staff Writer
EnteroMedics has submitted premarket approval (PMA) application to the US Food and Drug Administration (FDA) for Maestro Rechargeable System's VBLOC, a vagal blocking therapy to treat obesity.
Certification > News
US FDA approves Hologic’s Aptima HPV assay for usage on Panther system
By MDBR Staff Writer
Hologic, a developer of medical imaging systems and surgical products, has received approval for its Aptima HPV assay for use on its fully-automated Panther system from the US Food and Drug Administration (FDA).
Certification > News
Misonix wins clearance to sell BoneScalpel in China
By MDBR Staff Writer
Surgical device company Misonix has obtained clearance to market and sell its BoneScalpel, an ultrasonic osteotome system, in the People's Republic of China (PRC).
Certification > News
MBio Diagnostics wins ISO 13485: 2003 certification
By MDBR Staff Writer
US-based MBio Diagnostics has received ISO 13485: 2003 certification for its quality management system.
Certification > News
Promega launches automated clinical sample concentrator system
By MDBR Staff Writer
Promega, DNA-based human identification products provider, has launched its Maxwell CSC Instrument and integrated reagent kits for Blood DNA and DNA FFPE.
Certification > News
46-60 of 196 results