Considerations when outsourcing manufacture of medical devices

In the modern era of manufacturing its common for a company to make the decision to outsource part or full manufacturing of medical devices to a sub-contract manufacturer/critical supplier. There are many reasons for the medical device manufacturer to do this i.e. expertise, scale of manufacture, latest technology and cost. Its vitally important to select the right sub-contract/critical supplier manufacturer. How to find the right sub-contract/critical supplier manufacturer: Size – This will determine their ability to meet your manufacturing needs, whether this is with specialised equipment or the newest technologies. Consider the......

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Important Changes in the Regulatory Framework for IVDs

In house Class 4 IVDs – new manufacturer’s evidence accepted Goods new for laboratories that manufacture Class 4 in-house IVDs. A new conformity assessment procedure has been introduced. The following options are now applicable: TGA conformity assessment; or TGA issued Good Manufacturing Practice (GMP) licence (satisfying the requirements in the Australian Code of Good Manufacturing Practice for Blood and Blood Components, Human Tissues and Human Cellular Therapy Products); or NATA accreditation as a medical testing laboratory to ISO 15189 and compliance with the NPACC standard, Requirements for the development and use of......

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