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...
What are the main reasons that so many life science companies are using a Manual Paper QMS instead of digitizing their Quality Processes with an eQMS? The key topics are: “It takes too much time””The price is too high””Vendors are unaware...
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....
