M-Files QMS is a document management technology, which is used by SimplerQMS to build a ready-to-use eQMS Solution for the Life Science Industry. M-Files was founded in 1987 and over the course of 30 years, they have been developing, tweaking, and testing their...
When we look at the statistics, 75% of medical device startups never make it to the market. So, the real question is what makes the 25% succeed? Innovative medical devices often bring disruptive changes to the market to dramatically improve the quality of patients’...
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...
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...
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...
