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Showing posts tagged with: FDA

Premarket approval (PMA) or notification (510k)

Premarket approval (PMA) or notification (510k)

When someone is talking about pre-market approval or notification known as 510(k), they have in mind the US market. In the EU, the concept to get to the EU market is done differently. What you need to know to apply for approval or notification will be explained here below. For better understanding, you have to know...
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Post-market surveillance (PMS) of medical devices

Post-market surveillance (PMS) of medical devices

Let’s try to clear out all the mystery that stands behind this statement. We’ll start with its definition from the previous article where we have defined basic terms in the medical device industry: Medical device manufacturers, as well as other companies involved in the distribution of devices, must follow certain requirements and regulations once devices are...
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20 facts about FDA Approval Process for medical devices

20 facts about FDA Approval Process for medical devices

It is not easy for medical device manufacturers to face that torrent of information that awaits them when they need to face regulatory bodies and launch their device on the market.  Every company that plans to sell its medical device on US ground has to register with the FDA. In the following listing you will read...
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An effect of COVID-19 on upcoming  quality and regulatory interactions

An effect of COVID-19 on upcoming quality and regulatory interactions

COVID-19 is now in full swing. Its spread is felt through pressure on world healthcare organizations. Nonetheless, no delay in the regulatory approval of medical device products has been observed so far. Potential delays in regulatory communication and meetings will continue for months. 'Stay At Home' measures and the very limited allowable travel, with no...
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Wrap Jira in QMS

Wrap Jira in QMS

27th November 2019 Toronto, CA - QmsWrapper, a world-famous QMS System that helps Meddev startups and small businesses achieve and manage ISO 13485:2016 and 21 CFR 820, announces that the future is now available with the latest release where vision meets functionality.  Vs6.0 will radically change the way you look at QMS. It moves away from being...
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Cup of Joe 40# - Documents and procedures amendment

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...
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Cup of Joe 35# - Signing your electronic documents

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...
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Pitfalls and Best Practices in Establishing a Quality Manual

Pitfalls and Best Practices in Establishing a Quality Manual

It takes the same amount of time and effort to create a good quality manual as it does a bad one. Oftentimes, far less... In this article, we will discuss how to establish, operate and maintain a good one: Introduction (what is a QM, and what should include) Common mistakes in establishing a QM, and how to avoid them Pro...
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Weekly Cup of Joe #28 – Is Employee Training Worth the Investment?

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...
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Weekly Cup of Joe #27 – Validating With The Wrong Requirements

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...
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The Quality Manual F.A.Q. – Quality Manual Writing Tips

The Quality Manual F.A.Q. – Quality Manual Writing Tips

To pass a certification body audit, a Quality Management System must be an auditable entity with a neat Quality Manual. How to get useful ‘written stuff’? For hints on what to do, see the Quality manual writing tips part 2, in this short and clear infographic we collected 13 of the top F.A.Q.s and answers. If you want...
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