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…
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…
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…
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. As a medical device design engineer, you know every part of your design; you know how all the pieces fit together and…
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…
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…
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…
In a global environment, companies are facing countless complex, unique industry challenges. Quality becomes not just a buzzword but a true competitive advantage – companies that deliver the best quality products and services efficiently – succeed. ISO certification, (be it ISO9001, ISO13485…) communicates a commitment…
Successful startups and small businesses understand that although a DMS (Document Management Software) is essential to success it is outright critical for compliance. The top features requested in DM software reflect the growing needs of Startups and Small companies who cannot ignore the increasingly central role a DMS…
Elements of effective team collaboration & best practices Establishing and developing a productive and successful team can be tricky. Have your team ever struggled to collaborate successfully in real-time or online? Nowadays, working together remotely is a necessity for most teams and companies. We have to…
