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ISO

International product design company, IDC (Industrial Design Consultancy), has achieved certification for both ISO 13485 and ISO 9001 throughout its UK and China operations. Read more

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Ashley Philipp, marketing coordinator, Injectech highlights the new International Organisation for Standardisation (ISO) 80369 standards and its importance for ensuring patient safety. Read more

North America

To help streamline regulatory processes for medical devices across the world, the FDA has decided to replace its current system with ISO 13485, the organisation has announced. Read more

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Leti, a research institute of CEA Tech is to develop new ISO standards on microfluidics. Read more

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With new requirements on quality management for medical devices set for March 2019, FMI asks how OEMs can recognise whether suppliers will achieve certification on time? Read more

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Mack Molding, a custom plastics molder has announced it is gaining ISO 9001:2015 and ISO 13485:2016 of the international standards for general quality management and assurance, as well as for medical devices. Read more

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Product design and development firm, Product Creation Studio, has been awarded ISO 13485 certification, the internationally-recognised quality standard for medical devices. Read more

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Custom compounder Teknor Apex has expanded its supply capabilities in Asia for its Medalist medical thermoplast Elastomers (TPEs). Read more

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Canon Virginia, provider of custom manufacturing precision mould making, has announced it is extending its full range of manufacturing services to include medical device contracting manufacturing. Read more

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James Alexander, Procorre, explains how device manufacturers can prepare for the changes and gives practical steps on becoming fully compliant. Read more

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North Yorkshire-based electronic design firm, GSPK Design, has secured ISO quality accreditation, to help support the design and manufacturing of electronic devices for the medical device market. Read more

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The FDA is inviting medical device OEMs and other stakeholders to comment on its proposal to address the servicing of medical devices by third parties Read more

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The latest edition of ISO 13485, the quality management systems standard for the medical device industry, has been published Read more

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Solvay has introduced its high-performance Veradel HC A-301 polyethersulfone (PESU), which offers 
ISO 10993 biocompatibility for healthcare applications Read more

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Mission Plastics has received ISO 13485:2003 certification, an internationally recognised quality standard for design and manufacture of medical devices. Read more

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Testing testing: Laurence Lister, Toxikon, shares his white paper – Points to Consider in ISO 10993 Testing Read more

Opinion

Stick with it: Label solutions provider achieves ISO certification Read more

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