The Dawn of Integrated QMS… Part 2
Since developed by a medical device company, the priority was to design a QMS application that solves challenges facing medical device startups and companies.
The Dawn of Integrated QMS… Part 1
As regulatory and standards compliance increasingly play a critical role in business success, integrated compliance tools remain a sore point.
The Temptation of ISO 13485 Template Kits
On Internet you can find hundreds of templates for ISO 13485, offered by consultants and experts. But it is not so certain that you will get what is promised
Same Tasks over and over Again? Let a Workflow Process Help You.
In the world of regulations it is really easy to get confused. Processes and Workflows make sure that each step required to complete an action is completed.
QMS Expert vs QMS Expert...alias - Today Everybody is an Internet Certified QMS Expert
As a newly minted QMS manager in a startup, I turned to the internet for what to do. I had to realize that today everybody is an internet certified QMS expert.
Top Documentation Pain Points Solved With DM Software
Document Management Softwares combine paper and digital files into a single hub. Here are few pain points which can be eliminated by using a DM Software.
Risk as synonymous with uncertainty?
Risk management has become a separate branch of management science. But what is the difference between Risk and Uncertainty? How can we apply to a project?
Chat for Compliance – a hacker’s view!
The ongoing quest for compliance can sometimes be challenging when the needs are not always clear. How can a small team proceed when they are doing research?
ISO 13485:2016 Summary
The ISO 13485 revision includes significant changes in a number of important areas. The following infographic offers a summary of these changes.
8 Secret Benefits of Using Team Collaboration Tools
Working in a team can be a challenge. Here are 8 typical annoying situations and the 8 Secret Benefits that you get by using Team Communication tools.
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.