The Covid-19 pandemic has propelled the interest in an old topic, remote audits. The technology needed to perform a remote audit already exists, making this an attractive alternative to the long commutes required for an onsite audit. Although some certification bodies...
In this video, Jacob Sjørslev talks about what is needed to validate an Electronic Quality Management System (eQMS). This validation activity is needed according to ISO13485:2016 7.5.6, 21 CFR Part 11 Subpart B and Annex 11. The goal is to establish a level of...
Our vision is to be a preferred partner for small life science companies, that focus on high quality and efficient processes. The SimplerQMS application will often be the first IT-system investment done by start-up’s....
During the past months we have met with founders of 15 medical device startup’s in order to learn about their biggest challenges. We were especially interested in their struggles with gaining market access, because we knew from our ‘big company’ medical device...
Switching to a modern digital eQMS from a paper-based QMS will save a medical device startups time and money by supporting virtual collaboration, digital signatures, and automating your processes. Going digital to an Electronic Quality Management System (eQMS) can...
The regulatory requirements for medical device startups are significant. It’s imperative for your business, not to be ‘killed by paper’. In some cases even before you get to the market. This is why there has been a surge in the popularity of Electronic Quality...
