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Showing posts tagged with: ISO 13485

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What are the General requirements in ISO 13485 – Lesson 2

What are the General requirements in ISO 13485 – Lesson 2

Every ISO standard has the system of requirements and each one of them is described in segments. In general requirements, it’s established what is meant by: Developing and documenting QMS – Establish QMS Defining your QMS processes – Clarify the structure Supporting them – Support processes Managing QMS process changes – Manage changes Controlling your QMS outsourcing – Control outsourcing Validating your...
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Understand ISO 13485 - Lesson 1

Understand ISO 13485 - Lesson 1

Let’s say you have an idea of placing an innovative medical device on the market. That’s great, but you already know that going from idea to actual realization is not the whole picture, just the tip of the iceberg. Yes, there is a much larger part below the surface to know about, and it has...
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5 FAQs about ISO 13485

5 FAQs about ISO 13485

1. What is an ISO 13485? ISO 13485 is an international standard for establishing quality management in the medical device industry. It is an effective explanation to meet the comprehensive requirements for a QMS in the medical device industry. The other well-known QMS requirements to follow come from the US, as the FDA requires that the medical...
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20 things you need to know about SOP for medical devices

20 things you need to know about SOP for medical devices

So, you are a medical device creator and you reached to the point when you see that SOP (Standard Operating Procedure) is required by the FDA, ISO, and other regulatory bodies. But what SOP actually means? By definition, it’s a document that describes the regularly recurring operations relevant to the quality of the investigation. The aim...
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QMS Manager role in MedDev industry

QMS Manager role in MedDev industry

ISO 9001 sets out the criteria for a quality management system. Quality Management System (QMS) ensures that an organization, product or service is consistent. It is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction. It is expressed as the organizational...
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Jira is now “wrapped” with qmsWrapper

Jira is now “wrapped” with qmsWrapper

Now Medical Device startups and small businesses that use Jira can be connected to qmsWrapper. This integration will help medical device companies reduce their development risks and increase their agile effectiveness, whilst still keeping an eye on quality. “qmsWrapper got its name because it originally designed to ‘wrap’ Jira in a QMS blanket, to take advantage...
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Cup of Joe #46 - New superpower for MedDev through qmsWrappers TM

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...
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Top 10 medical device trade shows 2020 not to be missed

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. There is so much benefit to attend a trade show. We have listed 10 trade shows in the world for 2020, which we believe has...
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How CAPA should be verified?

How CAPA should be verified?

“Efficiency without Effectiveness misses the Purpose Effectiveness without Efficiency misses all the Profit Effectiveness with Efficiency brings Performance.” ― Martin U.  Ugwu   Verifying the effectiveness of corrective and preventive actions (CAPAs) closes the loop between identifying a problem and completing the actions to solve it. Reminder: The main purpose of corrective and preventive actions (CAPA) is to improve the organization processes...
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4 steps how to carry out RCA

4 steps how to carry out RCA

Why? Where? How? When? What? Most problems don’t have obvious solutions. That’s why they remain problems, and that’s why, it’s necessary to be aware of underlying causes, especially when planning to carry out a root cause analysis. Root cause analysis is basically a process with a systematic approach for identifying a problem. It provides companies a way to prevent...
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Cup of Joe 43# - Treat the cause, not the symptom

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...
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Cup of Joe 41# - 4 reasons - why eQMS over paper-based QMS

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...
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Ultimate Tips and Guidelines to Fine Tune Your Employee Trainings

Ultimate Tips and Guidelines to Fine Tune Your Employee Trainings

Tips and guidelines to create an efficient workforce and keep your business functioning at a high level. (ISO 90001, ISO13485, FDA510K)   Nobody wants to hire a person that is unable to do a job to a satisfactory standard. This is especially true when it comes to QMS related functions and activities. Besides, the candidate’s adequate competency...
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Validating or Not Validating for Intended Use?

Validating or Not Validating for Intended Use?

When I say Validation For Intended Use, most of you picture an extensive documentation required by ISO and FDA. Although Validation for intended use documentation is useful for several reasons (ensure accuracy, reliability, consistent intended performance, the ability to discern invalid or altered records, etc.) people mainly think of it as a regulatory requirement only. In FDA's...
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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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What if staying ISO and FDA compliant was easy?

What if staying ISO and FDA compliant was easy?

In the previous article, we took a closer look at ISO13485:2016 and the pending doomsday scenario. In this article, I’ll take a closer look at the similarities between ISO 13485:2016 and FDA QSRs. Similarities between ISO 13485:2016 and FDA QSR A quick reality check of ISO 13485:2016, reveals that it actually looks more, smells more and sounds...
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Weekly Cup of Joe #21 – References on Obsolete QMS Documents

Weekly Cup of Joe #21 – References on Obsolete QMS Documents

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.   The importance of identifying and updating all the documents that...
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​ISO Audit and the Company Image

​ISO Audit and the Company Image

The Company must have a true picture of itself. It is not enough to possess the required information related to legislation, internal and external issues and interested parties, all this data should be properly documented, this information has to be available to the relevant project team members, who have to ensure the right policies are...
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ISO 13485 – 2016 Checklist

ISO 13485 – 2016 Checklist

A checklist on where to start, and what to do first   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, you’re reading this because your strategy requires QMS oversight and your first question is likely “where to start” and “what...
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QMS documentation - “What should I document?”

QMS documentation - “What should I document?”

Good QMS documentation is essential for an effective quality management system. Properly structured documentation will make your operations much easier, while incorrect documentation will bring you nothing but trouble. Use qmsWrapper to structure your QMS documentation, follow the necessary steps and avoid those unpleasant last-minute surprises.    What has to be included in a QMS Documentation, regarding ISO? Usually,...
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