Showing posts tagged with: infographics

ISO 13485:2016 has set out requirements for a quality management system where you need to demonstrate your company’s ability to provide safe medical devices and related services that consistently meet customer and regulatory requirements. Learn more about the certification flow to certificate through this infographic. It’s more eye-catching than texts, or in other words, more attention-drawing. ...

CE mark? It’s a symbol, it’s a declaration, it’s a proof, it’s validation, it’s European. As a medical device manufacturer, you are aware of the importance of FDA approval, of course, if you are in America. If you are chasing the European market, you know about the CE mark. In case you are MedDev Start-up, planning to...

TM is now more effective and useful feature that serves as a dashboard for product development leading to submission. You build your Traceability Matrix as you develop your product... Key functions of qmsWrapper Traceability Matrix: track and show the relationships and connections between requirements end to end traceability design controls, by column tracking number automatically assigned and inherited export into a print-ready...

Now Medical Device startups and small businesses that use Jira can be connected to qmsWrapper. This integration will help medical device companies reduce their development risks and increase their agile effectiveness, whilst still keeping an eye on quality. “qmsWrapper got its name because it originally designed to ‘wrap’ Jira in a QMS blanket, to take advantage...

“Efficiency without Effectiveness misses the Purpose Effectiveness without Efficiency misses all the Profit Effectiveness with Efficiency brings Performance.” ― Martin U.  Ugwu   Verifying the effectiveness of corrective and preventive actions (CAPAs) closes the loop between identifying a problem and completing the actions to solve it. Reminder: The main purpose of corrective and preventive actions (CAPA) is to improve the organization processes...

The most important part of the manual is the description of the QMS The quality manual provides a wide range of benefits for organizations. Besides, that is easy to follow, it covers almost everything that company and its employees need to know about the ISO standards and what is expected of your quality management system. A bad...

To pass a certification body audit, a Quality Management System must be an auditable entity with a neat Quality Manual. How to get useful ‘written stuff’? For hints on what to do, see the Quality manual writing tips part 2, in this short and clear infographic we collected 13 of the top F.A.Q.s and answers. If you want...

  Document what you do and do what you document Quality Manual is the foundation and framework from where you build your organization. It is a plan, which sets the direction and navigates the organization within the defined parameters. Like any plan, it is good to revisit once in a while and check against the agreed objectives,...

Data loss or damage is costly, extremely risky and can affect your brand reputation. Perils might come in many forms, as natural disasters (e.g. hurricanes, floods, fire) or uncontrollable human errors, power surges, technical malfunctions and increasingly malware attacks. You need a backup plan and the ability to restore your data quickly. Warning steps through infographics While...

Advantages in numbers Every industry or organization is working hard to achieve success and to ensure their service and product safety. Nowadays, it is hard to imagine the work without an electronic, cloud-based QMS or project management tool.  Cloud-based tools are the most searched software today, they are easy to obtain through the internet, they are flexible,...

Ballance as a secret to success Every given task needs to have a clear priority. In the medical device industry, when everything seems so important, and you are not sure where to begin, it's crucial to collect all your tasks, identify them, maybe order them by estimated effort, etc.. Especially if you are a beginner, your to-do...

One of the challenges managers face today is that all is happening in the present time and everything is urgent. But, many of them are not focused on the most important things they need to do to help their team be successful.   How Managers Make Things Worse? Good time management requires driving attention from activities to results: being...

Today’s businesses are up against more challenges than ever in the past. While some businesses think they don’t need to move away from paper, getting started with this practice has never been so crucial. Document management software makes it easy for businesses to combine paper and digital files into a single hub, as physical documents. Companies that...

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 on 1st March 2016. It focuses on how companies...

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 information is a tough job. More than that - compliance becomes a...

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   The new generation of Document Management Software offers various solutions on a...

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 get used to using online collaboration tools. These tools allow...

ISO 12651-2 defines a document as "recorded information or object which can be treated as a unit". Err… Yup!... Got it!... Been treating recorded objects as a unit for, well… forever…   Sometimes you just have to admire their creativity! Compliance requests essentials On the more serious side, we’re still talking compliance and for that, there are 6...