Medical Device Contract Manufacturing

Medical Device Contract Manufacturing is a type of outsourcing in which a company creates whole products or a single part a larger product. This is valid in the medical device industry, too. OEM (Original Equipment Manufacturer) of medical devices are companies that, in general, centring around a particular area of expertise, for example moulding, assembly,…

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MHRA Answers to Comments, Addresses Brexit Impact: Falsified Medicines Directive

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) last month responded to comments on its proposal to implement packaging safety features under the EU Falsified Medicines Directive (FMD). The safety features, which include requiring a unique identifier comprised of a 2D data matrix code and human readable information and an anti-tampering device on the packaging…

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MDUFA Report commend CDRH attempts to upgrade medical device review processes

Efforts at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) to upgrade the medical device review process under the Medical Device User Fee Amendments of 2012 (MDUFA III) “have been very effective,” found a new report developed by Booz Allen Hamilton, a management and information technology consulting firm. The report satisfies a…

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TGA Propel for Total Product Lifecycle Approach to Medical Device Cybersecurity

New draft guidance from Australia’s Therapeutic Goods Administration (TGA) encouraged use of regulatory policies that span total product lifecycles (TPLC) to ensure medical device cybersecurity. A “growing area of interest” for TGA relates to “a large number” of class II, class III and active implantable devices registered in Australia that contain “electronic parts with installed…

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