Cup of Joe #47 - 2 Risk Modules
A new Risk Analysis Module is introduced to help focus on the relationship between requirements, design, and benefits, with an emphasis on risk-based design.
Enterprise-grade Processing Engine
Massive update of the year is happening and qmsWrapper’s Users will be thrilled to find out what is new in one of the 4 upgrades – Process Engine.
The New Risk Module supports risk-based design
The Risk Analysis Module becomes a very important update. Changes will make Risk Assessment much easier and clearer.
The Ultimate Content List of Technical File for CE marking
Some general details of the kind of information which will be required in the Technical File. As a general guide, the following items should be included.
8 things to know about CE approval process for Medical Devices
Determination EU Medical Device Directive which applies, Device Classification, Implementation of QMS, Technical File Preparation, etc.
5 things you must know about CE Mark
5 Answers on Most Important Things You Should Know About CE Mark.
A new Traceability Matrix so powerful, it becomes the products dashboard
qmsWrappers Traceability Matrix clearly demonstrates to auditors the connection between the requirements, its design inputs, validation and verification, etc.
Jira is now “wrapped” with qmsWrapper
qmsWrapper has become the right choice for Jira users who need Quality Management System.
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.