It’s quite easy to mix up the Failure Mode and Effects Analysis (FMEA) from IEC 60812:2018 and the Hazard Traceability Matrix (HTM) in the ISO 14971:2019. Especially since nothing prevents a company from using these terms interchangeably or using different terms...
Choosing the right consultancy is a cumbersome task for any medical device organization. However, the right consultant will make up for it with valuable information. Experience of relevant consultants can help you with regulatory compliance, device design optimization...
Selecting the right Consulting service provider for any pharmaceutical organization is crucial to ensure that the company continuously produces quality products. The relevant experience and expertise of a consultant can help with preparation for regulatory...
How can you recognize a good Electronic Quality Management System Software (eQMS) and what to look out for when shopping for one? Before we dive into it, we need to address what a good eQMS is and what value can it bring to your business. Electronic Quality Management...
An Electronic Quality Management System (eQMS) is a new digitalized approach to Quality Management Systems (QMS). By using advanced IT infrastructures and technologies, the eQMS supports efficient processes and avoids unnecessary mistakes. But how does it differ from...
