Cup of Joe #46 - New superpower for MedDev through qmsWrappers TM
Medical device manufacturers will enjoy Multiuser TM which brings a valuable couple of benefits: save time, help you work faster, it's more effective.
Wrap Jira in QMS
qmsWrapper announces 4 major upgrades: Traceability Matrix, Risk Module, Process Engine, and integration with Jira.
Top 10 medical device trade shows 2020 not to be missed
Tradeshows are an excellent opportunity for exhibiting the newest products and any kind of innovation that your company has made. Check the top 10.
Cup of Joe #45 - How to choose a good manufacturer?
It’s not an easy task to find a good outsourced manufacturer for your needs, for your medical device that should conquer the market.
THE NEW MDR 2020 – all you need to know
The New regulation (MDR 2020) is knocking on a door to Medical Device manufacturers. Transition time is running out, it’s just 6 months away.
Cup of Joe 44# - Whose monitoring responsibility is when you have outsourced production?
When someone owns a medical device company, but not having a space or supplies for producing equipment, then they hire a contractor, outsourced manufacturer.
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.
4 steps how to carry out RCA
Root cause analysis is basically a process with a systematic approach for identifying a problem
Cup of Joe 43# - Treat the cause, not the symptom
Root Cause Analysis is something that we all do when we want to solve a problem for good. But what RCA actually means?
Cup of Joe 42# - Dealing with CAPA
Failure to stick to proper corrective and preventive actions is considered a violation of regulations on good manufacturing practices.
Cup of Joe 41# - 4 reasons - why eQMS over paper-based QMS
When implementing and maintaining ISO standards such as ISO 13485, it is burdensome to maintain paper-based documentation and it’s very time-consuming.
CAPA Checklist - Step by Step Guide
Besides its compulsory requirement, CAPA helps companies to enhance their quality system to reduce risks and avoid potential problems in the future.
Correct way to follow procedures and processes
Every company must have a set of procedures and processes to ensure that they are in compliance with regulations.
Cup of Joe 40# - Documents and procedures amendment
It's one thing to become ISO certified, but maintaining the certification is another thing with all the updates and new records.
Cup of Joe 39# - Key factor during an audit–prepared employees
A successful audit relies on communication. The most important step is the preparation of employees for how to interact with the auditors.
Cup of Joe 38# - There is such a thing like painless audit?
How to overcome the auditor's visit that always generates tension and anxiety? Track our guide.
Cup of Joe 37# - Why we have to perform an audit?
At work, nothing raises the hairs on the back of your neck like the word “audit”. Find out why it is that much important.
Cup of Joe 36# - Scary word “Audit”
Audits are carried out in order to confirm that the individual elements within the system are effective and suitable for achieving the stated objectives.
Cup of Joe 35# - Signing your electronic documents
One of the main criteria for an eQMS is to have implemented an electronic signature. Why? How?
Cup of Joe 34# - How to organize your folders?
Most of the startups and small companies have a problem with organizing folders, especially if they are still using a paper-based QMS.
Cup of Joe 33# - Revision History helps you with transferring to eQMS
One of the main fears when transferring from paper-based to eQMS is how to handle a lot of file versions, how should we name them, etc.
Cup of Joe 32# - Good Customer Service Reduces Problems
While you can’t run a perfect business with all smooth situations, at qmsWrapper we can ensure friction doesn’t become an issue.
Weekly Cup of Joe 31# - Move Your Budget into the Right Direction
There are countless benefits to implementing a QMS. Think of the investment in modern QMS software as an investment in preventing quality issues.
Top 20 Medical Device Conferences and Trade Shows 2019
We scoured the web for high-quality conferences in 2019 and made a list that every medical device manufacturer must attend.
Weekly Cup of Joe 30# – DHFs & CE Technicals with Traceability Matrix
The Traceability Matrix in qmsWrapper™ is fully integrated into the project and quality management.