To sell your medical device across the European Union, you must have a CE marking of conformity. Manufacturers of medical and in vitro diagnostic devices that wish to be part of the European Economic Area market need to adhere to regulatory requirements to ensure...
The complete documentation about the manufacturing and tracking of every medical device that your company sells is contained in a Device History Record (DHR). As per current international regulatory guidelines, your medical device company must maintain DHRs (or...
As a medical device manufacturer planning to sell your devices in the European Union (EU) market, you will first need to demonstrate compliance with EU regulatory requirements. You will ascertain this conformity by preparing meticulous information about the design,...
Being a medical devices company, you are well aware of the fact that your products must be made to the highest standards and serve their intended purpose. Let us take the example of absorbable sutures, a Class III medical device, which your company manufactures and...
ISO 13485 audit provides an objective measure of the organizations’ processes and regulatory compliance with the latest ISO 13485:2016 standard. Let us say that you are a medical device manufacturer based in the US. You, therefore, need to be compliant with FDA rules...
CAPA consists of a specific set of actions that an organization must complete to resolve and eliminate recurring non-conformance. CAPAs are commonly used when medical devices are non-conforming. Let us say that your medical devices company is manufacturing lifesaving...
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