How CAPA should be verified?
Verifying the effectiveness of corrective and preventive actions (CAPAs) closes the loop between identifying a problem and completing the actions to solve it.
Correct way to follow procedures and processes
Every company has as part of its organization set of procedures and processes. The purpose of having procedures is to drive efficiencies towards fewer errors and resulting reworks, which can improve cost saving. Besides that, their purpose is also to make sure they are in compliance with regulations.
Top 20 Medical Device Conferences and Trade Shows 2019
The power of trade shows is impressive. From showcasing your newest products, to expand your customer base, close sales, keep an eye on your competition, expand your distributor network, meet face to face with your remote customers, etc.
Audit Day Fears are Gone! How Cardio-Phoenix carried out of an ISO Audit With Help from qmsWrapper
Read about how Medical device startup "Cardio-Phoenix" successfully carried out the audit with help of qmsWrapper.
Choosing a QMS system? Why you should seriously look at the new qmsWrapper!
It’s a cloud-based development and compliance management software, in layman’s terms, a QMS and Project management system specifically designed for medical device companies, including start-ups.
How to stay on top of your product development and easily organize your FDA and CE submission
The Traceability Matrix in qmsWrapper™ is fully integrated into the project and quality management. Map and Trace the design control relationships for your medical device.
Pitfalls and Best Practices in Establishing a Quality Manual
This article includes what is a QM, and what should include, Common mistakes & how to avoid them, Pro tips & best practices on how to do it right ...
Ultimate Tips and Guidelines to Fine Tune Your Employee Trainings
By equipping employees with the tools and knowledge to perform their jobs, you can expect better performance and a more cohesive workplace.
10 Pitfalls and 13 Best Practices in Establishing a Quality Manual
The quality manual covers almost everything that company and its employees need to know about the ISO standards and what is expected of your quality management system.
Validating or Not Validating for Intended Use?
Learn more about pitfalls, what you should do and benefits of establishing the Validation for Intended Use Documentation
The Quality Manual F.A.Q. – Quality Manual Writing Tips
Tips and answers on how to effectively write Quality Manual for your company
What if staying ISO and FDA compliant was easy?
A quick reality check of ISO 13485:2016, reveals that it actually looks more, smells more and sounds more, like FDA’s QSR.
The Quality Manual Alias the Quality Bible or the Quality DNA
Quality Manual is the foundation and framework from where you build your organisation. It is a plan, which sets the direction and navigates within the defined parameters.
Are MedDev companies ready for the ISO 13485:2016? “A Closer Look”
This is a real and topical question. At every MedDev or MedTec oriented exhibition this is the off-stage topic, actually more like main grippe session.
Do you know how secure your documents really are?
The following infographic will help you recognize the primary causes and warning signs for potential data loss and the top tips for prevention.
Hidden Pitfalls in the Risk Management Strategy
Risk management is one of the key factors in quality management. Effectively managed risks help companies achieve their goals.
Advantages of Cloud Based QMS and Project Management Software
In this infographic, we present the actual percentages of the improvements your company can achieve with a cloud-based QMS or Project management software.
The Purpose of a Quality Management System
The advantages to such integrated QMS systems is that ISO compliance is not limited to “reporting” or the tracking of reports to prove the quality, but rather is integrated into your workflow processes directly, so quality becomes everyone’s business throughout the workday.
Approval Workflows in QMS
QMS approval processes are supporting the accurate recording of acceptance or agreement in business documents.
Balancing Priorities when everything is #1
Every given task needs to have a clear priority. In the medical device industry, when everything seems so important it is a must to ...
Documents in a Paperless Office, Find a Needle in the Haystack
The QMS documentation can be impenetrable. How to outsmart the system? In many cases a simple document management system won’t even do the expected job.
Where Did the Time Go? - Poor Time Management
Good time management requires driving attention from activities to results: being busy isn’t the same as being effective.
Quality Manual or Workflow Processes? What should I establish first?
The Quality Manual requires many references to the applied company and the workflow processes. Synchronously, most quality management related references are advising to ...
QMS documentation - “What should I document?”
Good QMS documentation is essential for an effective quality management system. Properly structured documentation will make your operations much easier.
Project management and quality management 2017 - smart solution
QMS and PM software are usually put together from series of APIs, they are disjointed and all together operate like Dr Frankenstein’s creation.