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...
A Device Master Record (DMR) is a collection of all the records that must be used to produce a medical device product. Let’s imagine that your medical devices company is planning on manufacturing a new and improved coronary stent, which is a Class III medical device....
Design Controls indicate that the medical devices your company makes are both safe and efficacious for the end-users. Let us say that your R&D department has come with a brilliant idea for a knee implant that will eliminate the disadvantages of currently available...
