Quality management system

OD-OS GmbH at ESCRS 2023: Recent MDR certification of Navilas® underlines its advanced standard in retina lasers and opens path to new developments

Retrieved on: 
Thursday, September 7, 2023
Retina, I Am the Moon, Certification, Medical Device Regulation Act, Quality management system, MDR, PRP, Patient, Diabetic retinopathy, Automation, Medical device, EU

TELTOW, Germany, Sept. 7, 2023 /PRNewswire/ -- Just in time for the ESCRS conference taking place Sep 8-11, 2023 in Vienna, OD-OS GmbH is announcing that its Quality Management System and the Navilas® Laser System 577s have been certified in accordance with the Medical Devices Regulation (EU) 2017/745 (EU MDR). Navilas® is one of the first laser products for medical retina to achieve certification according to new MDR standards. The only navigated retina laser with integrated eye tracking technology is a step beyond traditional slit-lamp lasers. It is transforming posterior pole laser care thanks to enhanced precision, speed and digital integration paving the way to further standardization and automation. The 577nm yellow laser also includes a subthreshold microsecond pulsing and an anterior treatment mode.

Key Points: 
  • Navilas® is one of the first laser products for medical retina to achieve certification according to new MDR standards.
  • The only navigated retina laser with integrated eye tracking technology is a step beyond traditional slit-lamp lasers.
  • It is transforming posterior pole laser care thanks to enhanced precision, speed and digital integration paving the way to further standardization and automation.
  • Dr. Winfried Teiwes, Managing Director, OD-OS GmbH: "We are very proud to have passed this important quality review of our processes and products.

OD-OS GmbH at ESCRS 2023: Recent MDR certification of Navilas® underlines its advanced standard in retina lasers and opens path to new developments

Retrieved on: 
Thursday, September 7, 2023
Retina, I Am the Moon, Certification, Medical Device Regulation Act, Quality management system, MDR, PRP, Patient, Diabetic retinopathy, Automation, Medical device, EU

TELTOW, Germany, Sept. 7, 2023 /PRNewswire/ -- Just in time for the ESCRS conference taking place Sep 8-11, 2023 in Vienna, OD-OS GmbH is announcing that its Quality Management System and the Navilas® Laser System 577s have been certified in accordance with the Medical Devices Regulation (EU) 2017/745 (EU MDR). Navilas® is one of the first laser products for medical retina to achieve certification according to new MDR standards. The only navigated retina laser with integrated eye tracking technology is a step beyond traditional slit-lamp lasers. It is transforming posterior pole laser care thanks to enhanced precision, speed and digital integration paving the way to further standardization and automation. The 577nm yellow laser also includes a subthreshold microsecond pulsing and an anterior treatment mode.

Key Points: 
  • Navilas® is one of the first laser products for medical retina to achieve certification according to new MDR standards.
  • The only navigated retina laser with integrated eye tracking technology is a step beyond traditional slit-lamp lasers.
  • It is transforming posterior pole laser care thanks to enhanced precision, speed and digital integration paving the way to further standardization and automation.
  • Dr. Winfried Teiwes, Managing Director, OD-OS GmbH: "We are very proud to have passed this important quality review of our processes and products.

Neuromeka Achieves Triple ISO Certification Milestone, Continues U.S. Market Expansion Efforts

Retrieved on: 
Tuesday, September 5, 2023
Environmental management system, Occupational safety and health, Food, NSF, ISO, NSF International, Certification, ISO 9001, Quality management system, Occupational Safety and Health Act 1994, Trust, International Organization (journal), Safety, Medical device

AUSTIN, Texas, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Neuromeka, a global collaborative robot manufacturer, announced its recent attainment of three certifications from the International Organization for Standardization (ISO), including ISO 9001 (Quality Management System), ISO 14001 (Environmental Management System), ISO 45001 (Occupational Health and Safety Management System).

Key Points: 
  • ISO 9001 certification indicates Neuromeka's commitment to having rigorous standards across all its industrial operations, ensuring that customers consistently get high-quality products and services.
  • ISO 14001 defines requirements for an Environmental Management System, demonstrating Neuromeka's dedication to improving environmental performance by optimizing resource utilization and waste reduction.
  • These certifications mark a significant milestone for Neuromeka, as the company strives to enhance the trust and reliability of its products for a global market.
  • This certification further guarantees that Neuromeka adheres to the highest standards of safety and quality in the food and beverage industry.

Propel Software Delivers Rapid Implementation and Time to Value with Summer ‘23 Release

Retrieved on: 
Tuesday, August 22, 2023
Software, Technology, Other Technology, Data Management, PLM, Quality assurance, Quality management system, PVM, Leg, QMS, PIM, Summer, CPO, Video game

Propel Software , creator of the first product value management (PVM) platform, speeds product innovation with the availability of its new Accelerated Value Services.

Key Points: 
  • Propel Software , creator of the first product value management (PVM) platform, speeds product innovation with the availability of its new Accelerated Value Services.
  • Propel’s Accelerated Value Services provide operational excellence across product lifecycle management (PLM), quality management (QMS), and product information management (PIM) software solutions.
  • Cyberdontics, a leading innovator in image-guided robotic restorative dentistry, recently completed its Propel Accelerated Value Services implementation.
  • In the Summer ‘23 release, Propel also unveils new features tailored to improve business processes through enhanced user experiences.

Spectral MD Holdings, Ltd. (“Spectral MD” or the “Company”) ISO 13485 Certification Received for AI-Driven DeepView® Wound Imaging System

Retrieved on: 
Monday, August 14, 2023
DFU, AIM, QMS, Culture, ISO, Spectral, SMD, Certification, Organization, Diabetic foot ulcer, Physician, Algorithm, ISO 13485, Artificial intelligence, Quality management system, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Wound healing, Medical device, DALLAS, Burn

ISO 13485 is an internationally recognized standard that ensures the quality of medical device design, development, and production.

Key Points: 
  • ISO 13485 is an internationally recognized standard that ensures the quality of medical device design, development, and production.
  • To receive certification, organizations must demonstrate that their Quality Management Systems (QMS) deliver medical devices and related services that consistently meet stringent customer and regulatory requirements.
  • Spectral MD’s receipt of ISO 13485 certification follows the completion of a comprehensive audit of the Company’s QMS undertaken by an Independent Registrar earlier this year.
  • Niko Pagoulatos, Chief Operating Officer of Spectral MD, said: “The receipt of ISO 13485 confirms Spectral MD’s status as a global provider of medical devices that meet the highest standards of quality, reliability, and safety.

Spear Bio Receives ISO 13485:2016 Certification

Retrieved on: 
Thursday, August 17, 2023
Certification, Organization, Quality management system, BSI, International Organization (journal), Certificate, BSI Group, Infection, ISO, Medical device

WOBURN, Mass., Aug. 17, 2023 /PRNewswire/ -- Ultrasensitive immunoassays developer Spear Bio has announced that it has received ISO certification for operating a "Quality Management System which complies with the requirements of ISO 13485: 2016."

Key Points: 
  • WOBURN, Mass., Aug. 17, 2023 /PRNewswire/ -- Ultrasensitive immunoassays developer Spear Bio has announced that it has received ISO certification for operating a "Quality Management System which complies with the requirements of ISO 13485: 2016."
  • "Everyone at Spear Bio can be proud of this ISO certification" said Spear Bio CEO, Jerome Clavel.
  • According to the International Organization for Standardization (ISO), organizations can reap many benefits from implementing the ISO 13485 standard without undergoing the certification process.
  • However, third-party certification can demonstrate to regulators that companies have met all the ISO 13485 requirements.

Yugabyte Achieves ISO 22301 and ISO 9001 Certification

Retrieved on: 
Tuesday, August 8, 2023
Data Management, Security, IOT (Internet of Things), Apps, Applications, Technology, Software, Electronic Commerce, SQL, QMS, ISO, Risk assessment, BCMS, SOC, Certification, Information, International Organization for Standardization, ISO 9001, Quality management system, ISO 22301, Cloud database, International Organization (journal), Audit, Risk management, YugabyteDB

Yugabyte , the leading PostgreSQL-compatible distributed SQL database company, today announced that it has successfully achieved ISO 22301 and ISO 9001 certification encompassing the open source software, YugabyteDB , plus Yugabyte’s commercial DBaaS products, YugabyteDB Anywhere and YugabyteDB Managed .

Key Points: 
  • Yugabyte , the leading PostgreSQL-compatible distributed SQL database company, today announced that it has successfully achieved ISO 22301 and ISO 9001 certification encompassing the open source software, YugabyteDB , plus Yugabyte’s commercial DBaaS products, YugabyteDB Anywhere and YugabyteDB Managed .
  • Developed by the International Organization for Standardization (ISO), ISO 22301 and ISO 9001 are the international standards for business continuity planning and quality management systems, respectively.
  • Focused on building an all-inclusive approach, Yugabyte has implemented structured processes around business continuity, risk assessment, process optimization, and employee engagement to align with the requirements of ISO 22301 and ISO 9001.
  • Receiving both ISO 22301 and ISO 9001 is further proof of our commitment to providing our customers with a consistent, high-quality experience and our belief in transparent business processes,” said Maurice Olsen, Director, Information Security and Compliance at Yugabyte.

Microbix Successfully Upgrades Logistics Software Systems Achieves “Go-Live” with New ERP and eQMS Solutions

Retrieved on: 
Friday, August 4, 2023
Stock, ERP, Government, Quality management system, Collection, SKU, Medtech, CRM, OTCQX, Local government in Canada, TSX, Growth, Software

These logistics IT systems are intended to facilitate growth in sales of Microbix’s product lines and thereby enable achievement of its business objectives.

Key Points: 
  • These logistics IT systems are intended to facilitate growth in sales of Microbix’s product lines and thereby enable achievement of its business objectives.
  • Microbix announced its selection of new ERP and eQMS systems in March, 2022, with its goal being to achieve “Go-Live” with each by the end of fiscal 2023 (i.e., September 30, 2023).
  • That goal is now achieved, with the new ERP software supporting operations from raw materials procurement through to receivables collection.
  • These logistics software upgrades are deemed essential for Microbix to realize its objective of driving sales toward C$ 100 million per year while maintaining optimal quality and pricing for its customers.

PHASE Scientific Americas Announces Continued Growth with Investment of a New CLIA-Certified Medical Laboratory

Retrieved on: 
Wednesday, July 26, 2023
Biotechnology, Online Retail, Vacation, Travel, Health, General Health, Seniors, Convenience Store, Infectious Diseases, Retail, Consumer, Infection, California Department, Liquid biopsy, Licensure, Certification, California Department of Public Health, Quality management system, CLIA, Public health, Patient, Clinical Laboratory Improvement Amendments, Quality control, CDPH, Medical device, Medical imaging

PHASE Scientific Americas (PHASE Scientific), a fast-growing biotechnology company actively developing innovative solutions to revolutionize diagnostics in healthcare announces that their PHASE Scientific Medical Laboratory (PHASE Lab) has been certified by Clinical Laboratory Improvement Amendments (CLIA) and issued licensure by the California Department of Public Health (CDPH) to perform moderate and high-complexity testing.

Key Points: 
  • PHASE Scientific Americas (PHASE Scientific), a fast-growing biotechnology company actively developing innovative solutions to revolutionize diagnostics in healthcare announces that their PHASE Scientific Medical Laboratory (PHASE Lab) has been certified by Clinical Laboratory Improvement Amendments (CLIA) and issued licensure by the California Department of Public Health (CDPH) to perform moderate and high-complexity testing.
  • PHASE Lab has demonstrated that it operates in a manner that ensures high-quality standards in patient testing.
  • PHASE Scientific’s investment in the laboratory facility will enable the company to launch at-home testing services and professional oncology services.
  • “We are excited to grow and position PHASE to bring tremendous value to the diagnostic testing market.”
    To learn more about PHASE Scientific Americas, click here .

AmbioPharm, a Global Peptide CDMO

Retrieved on: 
Wednesday, July 26, 2023
Manufacturing, Other Manufacturing, Health, Pharmaceutical, Clinical Trials, GMP, QMS, Clinical quality management system, Hydrogenation, API, Toxicology, Research, History, Quality, Quality management system, CDMO, LPPS, Investment, FDA, Saudi Standards, Metrology and Quality Organization, SPPS, HPLC, Fine chemical

AmbioPharm , a worldwide leader in peptide API CDMO services, continues growth to meet capacity demands for late phase and commercial peptide production.

Key Points: 
  • AmbioPharm , a worldwide leader in peptide API CDMO services, continues growth to meet capacity demands for late phase and commercial peptide production.
  • A reliable peptide CDMO with manufacturing facilities both in China and the USA, AmbioPharm is ready to meet the needs of a global market.
  • A hydrogenation facility for Liquid Phase Peptide Synthesis (LPPS) was also recently completed and fully qualified.
  • Working in close collaboration with our Shanghai campus, we offer end-to-end peptide manufacturing for clinical and commercial applications.