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CHARLES BRADSHAW

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Enterprise-grade Processing Engine

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. qmsWrapper’s core functionality was transformed from a tasks-based system to an enterprise-grade Processing Engine – to better support and enable your business workflows. Along with the Process Editor, business...
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The New Risk Module supports risk-based design

The New Risk Module supports risk-based design

Risk Analysis Module becomes a very important update, next to other features: Traceability Matrix, Process Engine, and Jira integration. Changes will make Risk Assessment much easier and clearer. In the medical device world, risk-based design and development is the new norm. For FDA clearance and CE Mark certification, ISO14971 is essential. And in May of 2020, the...
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A new Traceability Matrix so powerful, it becomes the products dashboard

A new Traceability Matrix so powerful, it becomes the products dashboard

TM is now more effective and useful feature that serves as a dashboard for product development leading to submission. You build your Traceability Matrix as you develop your product... Key functions of qmsWrapper Traceability Matrix: track and show the relationships and connections between requirements end to end traceability design controls, by column tracking number automatically assigned and inherited export into a print-ready...
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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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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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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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THE NEW MDR 2020 – all you need to know

THE NEW MDR 2020 – all you need to know

  TO ALL MEDICAL DEVICE MANUFACTURERS   The New regulation (not directive anymore) is knocking on a door to Medical Device manufacturers. Transition time is running out, it’s just 6 months away. Are you ready? We will give you a few handy pieces of information that will provide you a clearer image of what is requested and help you go...
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CAPA Checklist - Step by Step Guide

CAPA Checklist - Step by Step Guide

CAPA – Corrective action Preventive action The purpose of corrective and preventive action is to collect and inspect information, identify and examine the product or potential quality problems, then take suitable and effective corrective/preventive action. It’s a process of improvement taken to eliminate causes of possible malfunction, problem or another unwanted situation.  It’s also a process which...
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Correct way to follow procedures and processes

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. The procedure is correct, but are the follow-ups...
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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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The Quality Manual Alias the Quality Bible or the Quality DNA

The Quality Manual Alias the Quality Bible or the Quality DNA

  Document what you do and do what you document Quality Manual is the foundation and framework from where you build your organization. It is a plan, which sets the direction and navigates the organization within the defined parameters. Like any plan, it is good to revisit once in a while and check against the agreed objectives,...
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Hidden Pitfalls in the Risk Management Strategy

Hidden Pitfalls in the Risk Management Strategy

In our fast-paced world, the risks we have to take and manage, in order to continue to grow and to develop, evolve quickly. Effectively managed risks help companies achieve their goals. Products that are developed following quality standards, have improved the quality of life for thousands of people. The idea of improving the quality of life...
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ISO 9001 – 2015 Checklist

ISO 9001 – 2015 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 Medical Device 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”...
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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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The Temptation of ISO 13485 Template Kits

The Temptation of ISO 13485 Template Kits

Be careful what you use when building up your QMS system! The expanding Internet means more: more data, more collaboration, and more complex systems of interactions. You can find hundreds of both expensive and free templates for ISO 13485, offered by various consultants, companies and experts. But even if the ISO compliance is guaranteed on some...
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New Feature Announcement: "My Team", for qmsWrapper

New Feature Announcement: "My Team", for qmsWrapper

We are pleased to announce the release of the new team managing tool - My Team, in the Project Management Module for qmsWrapper. Projects are about teams, but the biggest project of all is managing your team. Announcing “My Team”, the newest element of qmsWrapper. “My Team” is a new module that gives managers the ability to...
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Management Through Quality, documenting compliance activities

Management Through Quality, documenting compliance activities

QMS, another layer of management or smart management.  If you’re thinking that a QMS system would be just another layer of management, think again! It’s true that most QMS systems are form-driven. Do an action, fill-a-form. Make a meeting, fill-a-form? The list is endless and if you forget, which is easy to do when deadlines are knocking...
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Top 13 plus 1 requested features in a DM Software

Top 13 plus 1 requested features in a DM Software

Successful startups and small businesses understand that although a DMS (Document Management Software) is essential to success it is outright critical for compliance. The top features requested in DM software reflect the growing needs of Startups and Small companies who cannot ignore the increasingly central role a DMS plays in their growth and success – both...
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ISO 13485:2016 - New terms to take note of

ISO 13485:2016 - New terms to take note of

Differences and similarities between the ISO 13485:2003 and ISO 13485:2016 editions. ISO 13485:2003 only had a few defined terms with clear definitions. However, in the new edition of ISO 13485:2016, sixteen new terms are added with longer definitions. Let's see what are the differences and similarities between the editions. Terms that remained the same Advisory notice - giving...
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