FDA Citation Tracking Tool Updated October 2022 I’m excited to share that QikSolve has helped us to update track and trend all the FDA inspection 483 citations from 20011 to 2021, the tool dynamically scrapes data from various live websites and databases and provides a single, secure portal which to track and trend data, or…
This popular blog has been updated in 2022 with the latest FDA data. As we all know there has been an increasing regulatory emphasis on the importance of Quality Metrics. Where there is a demand, there will also follow a supply and just in time, QikSolve have updated their free tool that scrapes data from various websites…
Certain medical devices utilize animal materials in their manufacture to provide performance characteristics that are more advantageous than non-animal-based materials. The use of animal material, however, carries the risk of transmitting infectious diseases when it is improperly collected, stored or processed (e.g. prion diseases). Transmissible Spongiform Encephalopathy (TSE) is a prion disease that can affect…
What is a Unique Device Identifier (UDI)? Unique Device Identifier (UDI) is a globally unique series of characters for each medical device on the market to: The Unique Device Identifier of a medical device typically includes two parts: History of UDI The first concept of UDI was signed into US law and added as part…
Have you ever come away from an audit feeling unsure of your own organisational processes? Do you sometimes feel that your organisation is alone or unique in the types of audit deficiencies observed? How do you compare with others with respect to audit deficiencies? Audit Deficiencies Reported by the TGA The Australian Therapeutic Goods Administration…
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