Take Back Compliance
The Art of Managing Through Quality
New Feature Announcement: "My Team", for qmsWrapper
“My Team” is a new module that gives managers the ability to track and monitor overall team progress and productivity, from individuals to the entire team.
Design Methodology Process - the guide through compliant design change
So you want to design a new version of your medical device? Here’s what you need to do to ensure ISO and FDA compliance.
Management Through Quality, documenting compliance activities
Most QMS systems are form driven. Do an action, fill-a-form, make a meeting... The list is endless and if you forget, then your QMS system has holes.
6 reasons why DM System makes a difference
This infographic will lead you through the benefits of the Document Management Software that has the potential to make your job 6 times easier and faster.
Creative Collaboration, Collaborative Compliance
Teamwork is about creating understanding and agreement when working on the same topic.
QMS Processes & ISO Compliance (ISO compliance in the business world and QMS processes)
The best QMS systems, or most effective QMS systems, take a more inclusive approach to business processes, combining ISO compliance with team collaboration, ...
Top 13 plus 1 requested features in a DM Software
These 13 + 1 requested features are the next big thing for Medical Device startups and small companies.
5+1 Ways to Improve Team Collaboration
As company hierarchies make fewer layers of management, success increasingly depends on good team collaboration. There are five essential elements for that.
6 Benefits of ISO Compliance
The benefits of getting ISO compliance can change your business fundamentally. Here are 6 of the main advantages.
6 Things Your DM Software Should Have
If we are talking about compliance, there are 6 “essentials” your document management system software should have.
7 Easiest Ways to Create a Championship Team Through Collaboration
Find out how to make your team effective and efficient through 7 simple steps.
QMS Manager: Job or Role?
A QMS manager is a one-person Job with a critical role. This role is central to keeping the focus on regulatory and standards compliance and quality assurance.
Management Through Quality, an Innovative Approach to Collaborative Compliance
Management through quality compliance is focus not on quality as the end game, but rather on quality as the process to achieve compliance.
Understanding Roles & Processes in ISO 13485:2016
In ISO 13485:2016 there are many new terms, definitions and requirements compared with the 2003 edition so here is a help to make things a more understandable.
Email is a Team Killer
Chat is not only for social media, but it’s also a great tool for keeping teams on topic. Chat focuses teams, brings teams together.
ISO 13485:2016 - New terms to take note of
In the new edition of ISO 13485:2016 16 new terms are added with longer definitions. Here is what are the differences and similarities between the editions.
ISO 13485:2016 – Creating a Glass Ceiling for Startups
ISO13485:2016 puts a glass ceiling on medical start-ups with a daunting new array certification requirements that will disproportionally impact them.