qmsWrapper Blog

As regulatory and standards compliance increasingly play a critical role in business success, integrated compliance tools remain a sore point.

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

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.

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.

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 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?

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?

The ISO 13485 revision includes significant changes in a number of important areas. The following infographic offers a summary of these changes.

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.

“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.

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.

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.

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.

Teamwork is about creating understanding and agreement when working on the same topic.

The best QMS systems, or most effective QMS systems, take a more inclusive approach to business processes, combining ISO compliance with team collaboration, ...

These 13 + 1 requested features are the next big thing for Medical Device startups and small companies.

As company hierarchies make fewer layers of management, success increasingly depends on good team collaboration. There are five essential elements for that.

The benefits of getting ISO compliance can change your business fundamentally. Here are 6 of the main advantages.

If we are talking about compliance, there are 6 “essentials” your document management system software should have.

Find out how to make your team effective and efficient through 7 simple steps.

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 compliance is focus not on quality as the end game, but rather on quality as the process to achieve compliance.

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.

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.

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.