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A rock climber on a steep rock face, representing the transition from uncertainty to managed risk through systematic risk assessment, mitigation, and documented proof in a medical device QMS.

Risk as synonymous with uncertainty?

” Risk /rɪsk/, noun the possibility that something unpleasant or unwelcome will happen. Synonyms: chance, uncertainty, unpredictability, instability, riskiness…” We’re dealing with countless risks in our daily life, like getting cut during apple slicing, or catching a cold if we get wet on a rainy… 

Close-up of a developer's workstation with a keyboard and monitor, representing the use of qmsWrapper’s integrated chat to capture real-time firmware development logs for DHF and QSR compliance.

Chat for Compliance – a hacker’s view!

This week we bring you a real-life experience example about how the qmsWrapper built-in chat function can turn the compliance documenting process into an easily manageable one. The ongoing quest for compliance can sometimes be challenging when the needs are not always clear. For example,… 

Infographic summary of ISO 13485:2016 key changes, featuring a world map and data charts representing global medical device quality management system requirements and regulatory compliance trends.

ISO 13485:2016 Summary

Medical Devices – Quality Management System – Requirements for Regulatory Purposes The world’s most popular standard for medical device quality management has been revised for the first time since 2003: Medical Devices – Quality Management System – Requirements for Regulatory Purposes. The revised standard ISO 13485:2016 was published… 

Infographic displaying the 8 secret benefits of team collaboration tools in QMS software, including time management, idea generation, and strategic project tracking for medical device compliance.

8 Secret Benefits of Using Team Collaboration Tools

That will Boost Your Company’s compliance productivity. Working in a team can be a communication challenge, from rallying people around a project, chatting constantly, losing attachments in chat, sending a bunch of emails and trying to keep everyone on the same page, to organizing and disseminating… 

Medical device project management team collaborating in a boardroom meeting, demonstrating team-based compliance and resource coordination through the qmsWrapper My Team module.

New Feature Announcement: “My Team”, for qmsWrapper

We are pleased to announce the release of the new team managing tool – My Team, in the Project Management Module for qmsWrapper. Projects are about teams, but the biggest project of all is managing your team. Announcing “My Team”, the newest element of qmsWrapper. “My… 

Medical device quality team collaborating in a document library, representing integrated QSR documentation and 21 CFR 820 compliance through smart QMS software.

Management Through Quality, documenting compliance activities

QMS, another layer of management or smart management.  If you’re thinking that a QMS system would be just another layer of management, think again! It’s true that most QMS systems are form-driven. Do an action, fill-a-form. Make a meeting, fill-a-form? The list is endless and if you… 

Infographic showing 6 reasons why a Document Management System improves medical device compliance, including reduced administration, increased productivity, and enhanced data security for ISO 13485 and FDA 21 CFR Part 11.

6 reasons why DM System makes a difference

In today’s modern world there is no space for time-wasting. The challenge of time was best expressed by William Penn when he said, “Time is what we want most, but what we use worst”.  Managing time in a fast-growing business world requires serious sets of skills… 

A row of professional neckties in various colors and patterns, symbolizing the diverse roles and departments in a medical device company unified through integrated QMS processes and collaborative compliance.

Creative Collaboration, Collaborative Compliance

It’s official, workplace emails are an ineffective tool for managing projects. Don’t confuse Emailing a link to your team as collaboration – that’s ping-pong! And sending your team an email and asking them to either comment or provide input on a file, an idea, a suggestion…