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 PM system specifically designed for meddev companies.
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 mngt. Map and Trace the design control relationships for your meddev.
Weekly Cup of Joe 29# – Customer Feedback is a Wealth of Information
Improve Customer Retention and Ensure That You Keep the Finger on the Pulse. Joe will guide you through ISO compliance
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 ...
Weekly Cup of Joe #28 – Is Employee Training Worth the Investment?
Smart companies invest in the development of their employees. QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.
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 the company and its employees need to know about the ISO standards and what is expected of your QMS.
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
Weekly Cup of Joe #27 – Validating With The Wrong Requirements
Without specific parameters or with the wrong requirements, you might end up approving things that might turn out to be quite different from what you expected.
The Quality Manual F.A.Q. – Quality Manual Writing Tips
Tips and answers on how to effectively write Quality Manual for your company
Weekly Cup of Joe #26 – Advantages of An Integrated PM and QMS
Integrated PM and QM includes features such as QMS approval workflows, document history management, scheduling meetings, etc.
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.
Weekly Cup of Joe #25– Documenting Opportunities to Improve
Documenting improvements are more important that the ideas itself because an idea that is not documented, does not exist.
Weekly Cup of Joe #24 - Data Backup and Recovery Plan in QMS
qmsWrapper will secure cloud Quality& Project Management System solution to ensure up-time, diminish data loss, & maximise productivity ...
Weekly Cup of Joe #23– Corrective and Preventive Action (CAPA)
Ignoring preventive actions might sound like saving money at first, but not investing resources into improving processes will cost more on a long term.
Weekly Cup of Joe #22 – Risk Management Strategy in QMS
Your risk controls will have a direct impact on your design outputs. An inappropriate risk management strategy will lead to incorrect hazard evaluation.
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.
Weekly Cup of Joe #21 – References on Obsolete QMS Documents
Company policies should include and cover managing, identifying and updating all the documents that contain references to obsolete versions or documents.
ISO Audit and the Company Image
If your company would like to achieve ISO 13485 certification,provide a clear picture of the organisations context to the auditors.
ISO 9001 – 2015 Checklist
If you do QMS right, it’s not a burden, not an added layer of management that gets in the way. The following checklist will guide you.
Weekly Cup of Joe #19 –Projects in Wrong Place and Time
Few tips on Project requirements are one of the first things that have to be determined when starting a new project.