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For the foreign manufacturers who want to place their products on the Swiss medical device market, it is necessary to appoint a Swiss Authorized Representative. However, an agreement must be ensured between the manufacturer and the Representative before the Representative’s appointment. Need of the Swiss Authorized Representative For the non-Swiss…
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Top 5 International Standards for Medical Devices Industry
The medical device industry is amongst the most regulated industries in the world. Many regulations govern it, and many standards can be applied to ensure transparency in its processes. In this regard, the top five internationally acclaimed and recognized standards that can be mentioned here are: ISO 13485 ISO 14971…
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Important Guidelines for MDSAP
The MDSAP (Medical Device Single Audit Program) is a three-year-long audit cycle. These cycles can be listed down as follows: The Initial Audit Cycle Partial Surveillance Audit Complete Re-audit The Initial Audit Cycle The initial audit cycle is the first year audit cycle and is also known as “Initial Certification…
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