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Cup of Joe #49 – Do You Need A Consultant?
With the ever-changing global marketplace of today, medical device companies are feeling the pressure of competition, the pressure to provide the most value and highest quality in their medical products.
It's not an easy process to bring a medical device to market. Medical device companies operate in a complex global regulatory environment with continually changing standards....
Cup of Joe #48 – qmsWrapper: messaging from home
The Coronavirus (COVID-19) outbreak is creating a massive challenge for many businesses. Millions of people are taking refuge from the coronavirus by working at home.
qmsWrapper does not see any issue when it comes to working from home. We are cloud-based QMS software, and it’s made to support continued team connection and business flow. It also...
Cup of Joe #47 - 2 Risk Modules
It’s always good to think a step ahead, and exactly that is what our Cup of Joe wants to tell you about.
qmsWrapper is constantly working on improvements and keeps up with the changes in the market that considers Medical Device startups and manufacturers.
The new MDR is set to become applicable in May 2020. One of...
Cup of Joe #46 - New superpower for MedDev through qmsWrappers TM
Last week qmsWrapper announced the greatest upgrade of the year. New updates 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.
Traceability Matrix with an issue
Working in TM in the past had a...
Cup of Joe #45 - How to choose a good manufacturer?
Before making any big decision, it’s always recommendable to think it through. It’s not an easy task to find a good outsourced manufacturer for your needs, for your medical device that should conquer the market.
Especially if you don’t know much about the technical part but you are aware of what your product’s requirements are, getting...
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.
So, he is providing all the services regarding life-cycle products. If you think you've taken a heavy load off your back, you are wrong.
Please, read the regulations and standards again.
Let us remind...
Cup of Joe 43# - Treat the cause, not the symptom
What is the root cause analysis?
Root Cause Analysis is something that we all do when we want to solve a problem for good.
But what RCA actually means?
It means to find what caused the problem, to find out not only what went wrong in the beginning, but how, when and why as well.
Basically, RCA is...
Cup of Joe 42# - Dealing with CAPA
CAPA is a system that consists of improvements taken to eliminate the causes of non-conformities or any other undesirable situation within an organization’s process.
CAPA importance
Every company should develop a strategy for CAPA as part of its overall quality system.
To manage the suitable CAPA activity, it is important to track, manage and evaluate all different quality...
Cup of Joe 41# - 4 reasons - why eQMS over paper-based QMS
When implementing and maintain ISO standards 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.
Good organization is essential for guaranteed successful business. There are few reasons for choosing an eQMS over...
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.
Besides following the processes and procedures that were set, it's also required to improve processes and all recorded as evidence. That means keeping up with your documentation, updating procedures when the processes change, modify work...
Cup of Joe 39# - Key factor during an audit–prepared employees
A successful audit relies on communication. So, the preparation of employees in order to know exactly how to interact with the auditors when they arrive is one of the most important steps. This means Meeting! If the staff members are able to work collaboratively with the auditors, the audit will be conducted more efficiently, and...
Cup of Joe 38# - There is such a thing like painless audit?
An audit is the verification of activities – process or quality system in order to ensure compliance with 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!
Painless = prepared, the more prepared, the more...
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”.
What audit means to you?
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...
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.
A system audit also delivers objective evidence concerning the need for a reduction, elimination and most importantly, prevention of...
Cup of Joe 35# - Signing your electronic documents
One of the main criteria for an eQMS is to have implemented an electronic signature.
Much 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.
When we are talking about...
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. Where is this file? Is it under review? Is this draft version? Is it approved? The need to check it and review it, then approve can take time and mistakes can be weird...
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, should we import every single version?
You just need to upload the latest version without the number of that version (for example “Technical file”) and make a note in the file...
Cup of Joe 32# - Good Customer Service Reduces Problems
Problems are always going to arise for any business no matter how hard you try to avoid them. While you can’t run a perfect business with all smooth situations, at qmsWrapper we can ensure friction doesn’t become an issue. You can always voice your challenges, we treat every issue as special, and not just another...
Weekly Cup of Joe 31# - Move Your Budget into the Right Direction
There are countless benefits to implement a quality management system.
We can all agree that an organization’s quality performance affects its bottom line. So, think of the investment in modern QMS software as an investment in preventing quality issues.
How to choose the right software?
The problem is with so many QMS software out there to choose from,...
Weekly Cup of Joe 30# – DHFs & CE Technicals with Traceability Matrix
An effective traceability process is an essential requirement when developing medical device software and achieving regulatory compliance.
How to create a Traceability Matrix?
Traceability Matrix can be very difficult to create. It can take months to put together manually, especially without a proper tool. Creating and maintaining a TM can be time-consuming and difficult, not to mention all...
Weekly Cup of Joe 29# – Customer Feedback is a Wealth of Information
Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project... your strategy requires QMS oversight.
QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.
Improve Customer Retention and Ensure That You Keep the Finger on...
Weekly Cup of Joe #28 – Is Employee Training Worth the Investment?
Without proper employee training, business will likely see minimum success.
Smart companies invest in the development of their employees.
QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.
Employee Training is deemed as the most important thing where the employees feel valued and develop an attachment to the overall mission of...
Weekly Cup of Joe #27 – Validating With The Wrong Requirements
Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project... your strategy requires QMS oversight.
QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.
Validating your system for FDA and ISO
Both FDA and ISO13485...
Weekly Cup of Joe #26 – Advantages of An Integrated PM and QMS
Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project... your strategy requires QMS oversight.
QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.
Bolt-on Quality Management Apps put the cart before the horse
The mistake...
Weekly Cup of Joe #25– Documenting Opportunities to Improve
Whether you are freshly minted into the QMS position or you are a founder of a Startup or a product manager with a new project…your strategy requires QMS oversight.
MS Joe will guide you with handy tips & tricks to streamline your way to compliance.
The Relation Between Risk Assessment and Opportunities to Improve
Companies often fail to...