Take Back Compliance
The Art of Managing Through Quality
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
As a medical device manufacturer which wants to place its product on the European market, you must be aware of all requirements to do so. Of course, one of the first things, you need to comply with Europe’s Medical Device Regulation (MDR).
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 inspectors/auditors the connection between the requirements, its design inputs, validation and verification, risk analysis, etc.
Jira is now “wrapped” with qmsWrapper
The combination of JIRA brings a system in which Medical Device Startups are able to track, manage and organise all CE Technical Files and FDA Design History Files, and do it in the most effective manner possible.
Cup of Joe #46 - New superpower for MedDev through qmsWrappers TM
News in qmsWrapper are Integration with Jira Software, updated Risk Module, and Process Engine and, best for the last - upgraded Traceability Matrix! Joe will introduce you to the first one of the super upgraded Traceability Matrix.
Wrap Jira in QMS
qmsWrapper announces 4 major upgrades. Our new Traceability Matrix as the new dashboard, and with Jira software integration,..., no struggle with FDA and Ce Mark submission.
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. It’s perfect for brand awareness, as well, as for promoting your business.
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
During the audit process, CAPA is always in the center of attention, and auditors are very strict when it comes to it. Also, 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 maintain ISO standard such as ISO 13485, it is burdensome to maintain paper-based documentation and it’s very time-consuming. It is quite a struggle to find information when needed in the thick of ‘forest’ of document history.
CAPA Checklist - Step by Step Guide
The purpose of corrective and preventive action is to collect and inspect information, identify and examine product or potential quality problem, then take suitable and effective corrective/preventive action.
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.
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. So, preparation of employees in order to know exactly how to interact with the auditors when they arrive is one of the most important steps.
Cup of Joe 38# - There is such a thing like painless audit?
An audit is verification of activities – process or quality system in order to ensure compliance to some requirements. As such audits always generate tension and anxiety – because you know that some stranger is coming to check your work and could give you a failing grade!
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”. Audits mean fault, mistake, short-coming and blame, fault, culpability all wrapped in disappointment – you have failed! The bullies incorporate love them! But the wise manager embraced them and uses them to pre-empt the bullies, by self-auditing.
Cup of Joe 36# - Scary word “Audit”
An Audit is the on-site verification activity of a process or quality system, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process, or production step.
Cup of Joe 35# - Signing your electronic documents
One of the main criteria for an eQMS is to have implemented an electronic signature. Many eQMS software have found many ways to handle this issue, but they all have to satisfy 21 CFR part 11. This part clearly paraphrases the fundamental rules of electronic signature implementation and control for compliance needs.