Quality management system

Integrating Design Controls and the Product Development Process for Effective and Compliant Medical Device Development (November 16, 2021) - ResearchAndMarkets.com

Thursday, October 21, 2021 - 11:16am

The "Integrating Design Controls and the Product Development Process for Effective and Compliant Medical Device Development" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Integrating Design Controls and the Product Development Process for Effective and Compliant Medical Device Development" training has been added to ResearchAndMarkets.com's offering.
  • Design controls alone, however, are not sufficient to address all of the needs of a medical device development program.
  • To address this gap, organizations employ some variation on a product development process to integrate design controls requirements with more general program management needs.
  • This seminar provides an overview of design controls requirements and proposes two models for incorporating these requirements into a more comprehensive product development process.

Software Program To Increase Efficiency In Image Interpretation

Wednesday, October 20, 2021 - 2:00pm

The software offers a simple and intuitive user interface that users can easily set-up and integrate into their production workflows for automatic processing.

Key Points: 
  • The software offers a simple and intuitive user interface that users can easily set-up and integrate into their production workflows for automatic processing.
  • Users can inspect high volumes of products and increase the reliability of interpretations.
  • This reduces labor costs as defects can be quickly detected and identified by the software and increases throughput and repeatability.
  • This software is compatible with other many image formats and is even compatible with competitive acquisition systems.

New at ATE 2021: Genuen Moves Automotive Companies Toward ISO 26262 Compliance with Model-Based Systems Engineering, Test as a Service, Custom HIL Systems, and Automated Manufacturing

Tuesday, October 19, 2021 - 1:00pm

Over the last two years, Genuen has grown in expertise (acquisitions of WTI, Butterfield, and Versatech) and service offerings ( test as a service ) to help companies move toward ISO 26262 compliance .

Key Points: 
  • Over the last two years, Genuen has grown in expertise (acquisitions of WTI, Butterfield, and Versatech) and service offerings ( test as a service ) to help companies move toward ISO 26262 compliance .
  • Reserve Time Now:ATE 2001 Attendees can schedule time with Genuen engineering staff to discuss current test or manufacturing challenges and needs for future compliance.
  • With model-based systems engineering (MBSE) Genuen helps clients visualize system requirements, facilitating communication across groups and reducing test requirements errors.
  • With extensive experience in mission-critical applications and regulatory compliance Genuen delivers custom test systems , hardware-in-the-loop (HIL) simulation , hydraulic test, dynamometer test, test platform development , and production robotics automation and control development .

BrightInsight Announces Appointment of Digital Biotech Veteran Meinhard F. Schmidt to Advisory Council

Tuesday, October 19, 2021 - 10:00am

SAN JOSE, Calif. and ZURICH, Switzerland, Oct. 19, 2021 (GLOBE NEWSWIRE) -- BrightInsight, Inc., provider of the leading global platform for biopharma and medtech regulated digital health solutions, announced today that Meinhard F. Schmidt has joined the BrightInsight Advisory Council.

Key Points: 
  • SAN JOSE, Calif. and ZURICH, Switzerland, Oct. 19, 2021 (GLOBE NEWSWIRE) -- BrightInsight, Inc., provider of the leading global platform for biopharma and medtech regulated digital health solutions, announced today that Meinhard F. Schmidt has joined the BrightInsight Advisory Council.
  • Meinhard Schmidt has been a friend and an unofficial advisor to BrightInsight, and we are honored to have him formally join our Advisory Council.
  • When building digital health products on the BrightInsight Platform, compliance is future-proofed as intended use changes scale across geographies.
  • BrightInsight and the BrightInsight logo are trademarks of BrightInsight, Inc. Other company and product names are for identification purposes only and may be trademarks of their respective owners.

Kubota Vision Receives ISO 13485:2016 Certification

Monday, October 18, 2021 - 4:00pm

Kubota Vision Inc. (Kubota Vision or the Company), a clinical-stage specialty ophthalmology company and a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), today announced that the company received Quality Management System - ISO 13485:2016 certification for the design and development of ophthalmic medical devices.

Key Points: 
  • Kubota Vision Inc. (Kubota Vision or the Company), a clinical-stage specialty ophthalmology company and a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), today announced that the company received Quality Management System - ISO 13485:2016 certification for the design and development of ophthalmic medical devices.
  • Kubota Pharmaceutical group continues to pursue developing ophthalmic medical devices to satisfy unmet medical needs worldwide.
  • We are in the final stage of launching Kubota GlassTM, a wearable device for myopia management, and continue maximizing the companys value and strategically enhancing our business, said Ryo Kubota, MD, PhD, Chairman, President and CEO of Kubota Vision Inc.
    Kubota Vision Inc. is a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596) committed to translating innovation into a diverse portfolio of drugs and devices to preserve and restore vision for millions of people worldwide.
  • https://www.kubotavision.com/ ; https://www.kubotaholdings.co.jp/en/
    Kubota Vision, the Kubota Vision logo and Kubota are registered trademarks or trademarks of Kubota Vision Inc. or Kubota Pharmaceutical Holdings in various jurisdictions.

NSF Celebrates DSHEA Anniversary with Open Access to New Dietary Supplement cGMP eLearning Courses

Monday, October 18, 2021 - 3:47pm

ANN ARBOR, Mich., Oct. 18, 2021 /PRNewswire/ -- To launch its new, self-paced eLearning courses and celebrate the 27th anniversary of the Dietary Supplement Health and Education Act of 1994 (DSHEA), NSF International is offering no-cost access to an introductory "GMPs for Dietary Supplements – 21 CFR 111 Overview" eLearning module. By using the promo code "DSHEA27" during the week of October 25 to 31, participants can access the normally $499 self-paced, digital training at no cost.

Key Points: 
  • ANN ARBOR, Mich., Oct. 18, 2021 /PRNewswire/ -- To launch its new, self-paced eLearning courses and celebrate the 27th anniversary of the Dietary Supplement Health and Education Act of 1994 (DSHEA), NSF International is offering no-cost access to an introductory "GMPs for Dietary Supplements 21 CFR 111 Overview" eLearning module.
  • By using the promo code "DSHEA27" during the week of October 25 to 31, participants can access the normally $499 self-paced, digital training at no cost.
  • "DSHEA was landmark legislation in 1994 and it's important for anyone in the dietary supplements industry to understand it," said Casey Coy, Senior Manager, Training and Consulting at NSF International.
  • The GMP overview course is one of four new, self-paced eLearning recently launched by NSF International.

Evergreen Theragnostics Completes New Jersey Manufacturing Facility

Monday, October 18, 2021 - 1:00pm

SPRINGFIELD, N.J., Oct. 18, 2021 /PRNewswire/ -- Evergreen Theragnostics, Inc., a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO), celebrated the grand opening in September of its new manufacturing facility in Springfield, New Jersey.

Key Points: 
  • SPRINGFIELD, N.J., Oct. 18, 2021 /PRNewswire/ -- Evergreen Theragnostics, Inc., a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO), celebrated the grand opening in September of its new manufacturing facility in Springfield, New Jersey.
  • From the new facility, Evergreen is ready and able to serve the manufacturing needs of companies developing and commercializing radiopharmaceuticals, from preclinical and early-stage clinical trials to full scale commercial manufacturing of approved products.
  • The newly built 14,000 square foot facility meets global cGMP (current Good Manufacturing Practice) standards for radiopharmaceutical manufacturing, including therapeutic and centrally distributed diagnostic products.
  • With a state-of-the-art global GMP facility, Evergreen provides highly reliable manufacturing services for therapeutic and centrally distributed diagnostic radiopharmaceuticals, from early development through commercialization.

North Star Imaging Welcomes New Global Sales Director

Thursday, October 14, 2021 - 2:00pm

As NSI's new Global Sales Director, Lih Fang is responsible for overall sales worldwide.

Key Points: 
  • As NSI's new Global Sales Director, Lih Fang is responsible for overall sales worldwide.
  • She brings extensive international experience in general management, sales, marketing, business development and operations to the organization.
  • North Star Imaging manufactures turn-key industrial 2D & 3D Digital Radiography & Computed Tomography (CT) X-ray equipment.
  • Industrial X-ray imaging is often used for R&D, Failure Analysis, Quality Control, Internal Measurements, High-Speed 3D Scanning, 3D Metrology & more.

[PRODUCT LAUNCH] - EPIQ QMS by Caliber - Enterprise Platform for Integrated Quality

Wednesday, October 13, 2021 - 4:20pm

PITTSBURGH and HYDERABAD, India, Oct. 13, 2021 /PRNewswire/ --Caliber launches the Enterprise Platform for Integrated Quality EPIQ.

Key Points: 
  • PITTSBURGH and HYDERABAD, India, Oct. 13, 2021 /PRNewswire/ --Caliber launches the Enterprise Platform for Integrated Quality EPIQ.
  • A quality management suite (QMS), EPIQ empowers regulated organizations to meet the changing compliance and digitalization needs of quality management.
  • EPIQ - Enterprise Platform for Integrated Quality - brings together the core quality functions like quality assurance, documentation, and personnel training.
  • Now, to meet the changing compliance and digitalization needs of quality management, Caliber launches this integrated, robust Quality Management System.

Black & Veatch Reaffirms Commitment to Stamping Out Bribery, Corruption

Wednesday, October 13, 2021 - 2:00pm

Bribery is a corrupt and destructive act, and here at Black & Veatch, we take our commitment to fair and transparent work practices very seriously, said Peter Loftspring, Chief Compliance Manager with Black & Veatch.

Key Points: 
  • Bribery is a corrupt and destructive act, and here at Black & Veatch, we take our commitment to fair and transparent work practices very seriously, said Peter Loftspring, Chief Compliance Manager with Black & Veatch.
  • This was a significant milestone, as the certification and recertification effort involved in-depth, in-person audits of every part of the business potentially exposed to corruption.
  • Black & Veatch holds several other ISO certifications, including the ISO 55000 family of International Asset Management Standards and ISO 9000 for Quality Management Systems.
  • Black & Veatch is an employee-owned global engineering, procurement, consulting and construction company with a more than 100-year track record of innovation in sustainable infrastructure.