The European Union In Vitro Diagnostic Regulation (EU IVDR) is the European law concerning placing in vitro diagnostic medical devices for human use and their accessories on the market. The IVDR was introduced in May 2017 to improve the safety and efficacy of in vitro...
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of multiple regulatory authorities. Audits are conducted by Auditing...
To sell and market your medical device across the European Union (EU), 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 must adhere to regulatory...
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...
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...
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