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Whether you are a small start-up, requiring an effective regulatory watch or a mature company looking for detailed… 

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Just before your certification audit by a third-party organization you may benefit from our pre-audit services to have a final…

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Regulations in many countries show increasing complexity and require medical device manufacturers to increase the level of regulatory knowledge…
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Medloft helps you ensure that your medical device complies with the applicable standards and regulatory requirements. We know how difficult…

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The new date of application of MDR is 26 May 2021. If you are planning to benefit from transitional provisions defined on  the revised Article 120, you can contact us for details…

The Medical Device Single Audit Program (MDSAP) is led by Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW.

This revision of the standard provides a basis for the quality management system in parallel to the EU MDR’s and other international regulatory changes which occurred since the second revision of the standard.

PMA process is generally known as a 510K application and is frequently used by manufacturers wishing to enter the market.

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young woman doctor’s hands close up preparing for an ultrasound device scan.