ISO13485

Amcor announces expansion of thermoforming production capacity to support healthcare customer growth in North America

Retrieved on: 
Wednesday, January 31, 2024

DEERFIELD, Ill., Jan. 31, 2024 /PRNewswire/ -- Amcor (NYSE: AMCR, ASX:AMC), a global leader in developing and producing responsible packaging solutions, today announced a significant expansion of its North American thermoforming capabilities for the healthcare market.

Key Points: 
  • DEERFIELD, Ill., Jan. 31, 2024 /PRNewswire/ -- Amcor (NYSE: AMCR, ASX:AMC), a global leader in developing and producing responsible packaging solutions, today announced a significant expansion of its North American thermoforming capabilities for the healthcare market.
  • The addition of automated, state-of-the art thermoforming equipment at Amcor's world-class healthcare manufacturing plant in Oshkosh, Wisconsin will support increasing demand from customers in the medical, pharmaceutical, and consumer health sectors.
  • The additional capacity will provide an efficient option for companies looking to partner with Amcor to support their growth ambitions.
  • "We're excited to offer our healthcare customers a critical supply solution by scaling up our manufacturing capabilities," said Art Castro, vice president and general manager of Amcor Flexibles North America Healthcare.

The Value of Local Program Management with Low-Cost-Country (LCC) Electronics Manufacturing - Ark Electronics

Retrieved on: 
Wednesday, January 10, 2024

Those LCC cost-savings often come with language barriers, multiple time differences, and cultural complexities making effective interaction across the teams very difficult.

Key Points: 
  • Those LCC cost-savings often come with language barriers, multiple time differences, and cultural complexities making effective interaction across the teams very difficult.
  • What truly differentiates Ark Electronics from most other companies with factories in LCC's is our English-speaking, North American, and European-based manufacturing leadership team .
  • This global reach and local expertise approach plays to our strength in effective program management, ensuring timely execution, adherence to quality standards, and client satisfaction."
  • Ark also holds multiple ISO and other quality certifications including ISO9001, ISO14001, ISO13485, ISO27001, ISO45001, and IATF 19649.

RRD Answers Industry's Call for Consolidated Supplier Solutions with Specialized Life Sciences Platform

Retrieved on: 
Tuesday, December 12, 2023

Donnelley & Sons Company (RRD), a leading global provider of marketing, packaging, print, and supply chain solutions, has introduced a comprehensive solution for the commercialization of life sciences products.

Key Points: 
  • Donnelley & Sons Company (RRD), a leading global provider of marketing, packaging, print, and supply chain solutions, has introduced a comprehensive solution for the commercialization of life sciences products.
  • With a focus on marketing communications and the secondary packaging supply chain, this specialized offering from RRD’s Life Sciences group meets the industry’s growing need for consolidated supplier solutions amid increasing regulatory scrutiny.
  • “In this era of supplier consolidation, life sciences companies are looking for reliable industry partners who can deliver solutions that promise value, compliance, and resilience across their product’s life cycle,” says John Pecaric, Chief Operating Officer, RRD.
  • The company offers the industry’s most trusted portfolio of creative execution and world-wide business process consulting, with services designed to lower environmental impact.

Relu® reaches medical quality standards with ISO13485 certification

Retrieved on: 
Tuesday, September 12, 2023

LEUVEN, Belgium, Sept. 12, 2023 /PRNewswire/ -- Relu, an OEM software provider in the dental industry, obtains ISO13485 certification from EU Notified Body Kiwa Dare.

Key Points: 
  • LEUVEN, Belgium, Sept. 12, 2023 /PRNewswire/ -- Relu, an OEM software provider in the dental industry, obtains ISO13485 certification from EU Notified Body Kiwa Dare.
  • ISO13485 is the global quality standard for medical device companies.
  • This ISO13485 certification will further increase the quality of Relu's product, besides reducing the regulatory work of their partners when integrating AI in their medical device software.
  • "This certification demonstrates our commitment to international quality and regulatory standards.

Relu® reaches medical quality standards with ISO13485 certification

Retrieved on: 
Tuesday, September 12, 2023

LEUVEN, Belgium, Sept. 12, 2023 /PRNewswire/ -- Relu, an OEM software provider in the dental industry, obtains ISO13485 certification from EU Notified Body Kiwa Dare.

Key Points: 
  • LEUVEN, Belgium, Sept. 12, 2023 /PRNewswire/ -- Relu, an OEM software provider in the dental industry, obtains ISO13485 certification from EU Notified Body Kiwa Dare.
  • ISO13485 is the global quality standard for medical device companies.
  • This ISO13485 certification will further increase the quality of Relu's product, besides reducing the regulatory work of their partners when integrating AI in their medical device software.
  • "This certification demonstrates our commitment to international quality and regulatory standards.

Eminence Opens New GMP Cell Culture Media Manufacturing Facility

Retrieved on: 
Thursday, September 7, 2023

SUZHOU, China and BOSTON, Sept. 7, 2023 /PRNewswire/ -- Eminence Biotechnology (Suzhou) Co., Ltd. ("Eminence") is delighted to announce that its state-of-the-art facility for the commercial production of cell culture media ("the new facility") is now fully operational.

Key Points: 
  • SUZHOU, China and BOSTON, Sept. 7, 2023 /PRNewswire/ -- Eminence Biotechnology (Suzhou) Co., Ltd. ("Eminence") is delighted to announce that its state-of-the-art facility for the commercial production of cell culture media ("the new facility") is now fully operational.
  • Equipped with cutting-edge vertical pin-milling manufacturing technology and bolstered by world-class utility systems, the new facility adheres to international GMP standards, ISO9001, and ISO13485 regulations.
  • It is designed to provide biopharmaceutical companies worldwide with consistently high-quality, batch-to-batch stable cell culture media products.
  • Frank Song, Chairman and CEO of Eminence, commented, "From the very beginning, our focus has been firmly set on the field of cell culture media.

Eminence Opens New GMP Cell Culture Media Manufacturing Facility

Retrieved on: 
Thursday, September 7, 2023

SUZHOU, China and BOSTON, Sept. 7, 2023 /PRNewswire/ -- Eminence Biotechnology (Suzhou) Co., Ltd. ("Eminence") is delighted to announce that its state-of-the-art facility for the commercial production of cell culture media ("the new facility") is now fully operational.

Key Points: 
  • SUZHOU, China and BOSTON, Sept. 7, 2023 /PRNewswire/ -- Eminence Biotechnology (Suzhou) Co., Ltd. ("Eminence") is delighted to announce that its state-of-the-art facility for the commercial production of cell culture media ("the new facility") is now fully operational.
  • Equipped with cutting-edge vertical pin-milling manufacturing technology and bolstered by world-class utility systems, the new facility adheres to international GMP standards, ISO9001, and ISO13485 regulations.
  • It is designed to provide biopharmaceutical companies worldwide with consistently high-quality, batch-to-batch stable cell culture media products.
  • Frank Song, Chairman and CEO of Eminence, commented, "From the very beginning, our focus has been firmly set on the field of cell culture media.

DiaCarta and HMC/HML Team up for Customizing Lab Development Test Validations and Compliances in the US Market

Retrieved on: 
Monday, July 24, 2023

The partnership will help companies who have developed novel IVD tests but do not have the capacity to bring the products for FDA approval, or to take the tests to clinical labs to serve healthcare providers and patients.

Key Points: 
  • The partnership will help companies who have developed novel IVD tests but do not have the capacity to bring the products for FDA approval, or to take the tests to clinical labs to serve healthcare providers and patients.
  • “DiaCarta has established high-quality systems not only for its IVD products under ISO13485 compliance, but also the LDT testing venues at its CAP/CLIA lab in California.
  • “Not only do we have successful experiences validating LDT assays for our clients, DiaCarta has also closely worked with CMS for coding, billing and reimbursement of the new tests.”
    Both DiaCarta and HMC/HML will attend 2023 AACC Annual Scientific Meeting and Clinical Lab Expo on July 23 to 27, Anaheim, California.
  • Their products/services will be presented at booths #4451 for DiaCarta and #3474 for HMC/HML.

Duoning Biotech Acquires PreFluid to Strengthen Fluid Management Solutions

Retrieved on: 
Tuesday, July 18, 2023

PreFluid's peristaltic pumps are widely used in medical, pharmaceutical, chemical and environmental industries worldwide

Key Points: 
  • PreFluid's peristaltic pumps are widely used in medical, pharmaceutical, chemical and environmental industries worldwide
    SHANGHAI, July 18, 2023 /PRNewswire/ -- Duoning Biotechnology Co., Ltd. ("Duoning Biotech") has used Shanghai Duoning Yuexi Biological Technology Co., Ltd. ("Duoning Yuexi") to sign an agreement to acquire Changzhou PreFluid Technology Co., Ltd. ("PreFluid"), a professional manufacturer of peristaltic pumps, expanding its key product portfolio related to fluid transport and upgrading the fluid management solutions.
  • Founded in 2007, PreFluid is committed to providing comprehensive, professional and customizable peristaltic pump solutions.
  • With a senior R&D team and a professional quality control team, the company develops high-quality standardized products while offering different fluid solutions to meet customers' needs.
  • Chu Jiangbo, Founder and GM of PreFluid, said, "We are grateful to Duoning Biotech for its recognition and appreciation.

Intech Expands Manufacturing Capacity for Surgical Containers: ISO13485 Certified Facility Now Open in Rockaway, NJ

Retrieved on: 
Thursday, May 11, 2023

ROCKAWAY, N.J., May 11, 2023 /PRNewswire-PRWeb/ -- Intech, the market leader in the manufacturing of orthopedic medical devices, today announced that its new Intech Cases Inc. facility in Rockaway, New Jersey, has been awarded ISO13485 certification by AFNOR. Dedicated to the manufacturing of surgical cases, trays and caddies for the orthopedic industry, this 11,000 sq.ft. expansion allows Intech to further enhance its competitive responsiveness by increasing capacity to meet the growing demand for cases & trays in the United States.

Key Points: 
  • The expansion allows Intech to continue enhancing competitive responsiveness to meet the growing demand for cases & trays.
  • ROCKAWAY, N.J., May 11, 2023 /PRNewswire-PRWeb/ -- Intech, the market leader in the manufacturing of orthopedic medical devices, today announced that its new Intech Cases Inc. facility in Rockaway, New Jersey, has been awarded ISO13485 certification by AFNOR.
  • Dedicated to the manufacturing of surgical cases, trays and caddies for the orthopedic industry, this 11,000 sq.ft.
  • expansion allows Intech to further enhance its competitive responsiveness by increasing capacity to meet the growing demand for cases & trays in the United States.