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Timea Torok Brand Manager / Project and Marketing Consultant at qmsWrapper. Constantly ‘selling’ people on ideas, tasks, and decisions.
Top 20 Medical Device Conferences and Trade Shows 2019

Top 20 Medical Device Conferences and Trade Shows 2019

The power of trade shows is impressive. From showcasing your newest products, to expand your customer base, close sales, keep an eye on your competition, expand your distributor network, meet face to face with your remote customers, expand your industry contacts, recruit new employees, explore new product offerings, keep up on the latest regulatory trends,...
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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 it include) Common mistakes in establishing a QM, and how to...
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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. Beside the candidate’s adequate competency...
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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, I 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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Are companies ready for the ISO 13485:2016? “a closer look”

Are companies ready for the ISO 13485:2016? “a closer look”

Surprisingly this is a real and topical question. At every MedDev or MedTec oriented exhibition this is the off-stage topic, actually more like main grippe session. The 2016 version requires a lot more emphasis on risk management and embedding risk management into the quality system processes. But really there are two issues in play with respect...
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The Purpose of a Quality Management System

The Purpose of a Quality Management System

Small businesses typically face a struggle to succeed in a competitive marketplace. Companies that offer quality services or products are better positioned to not only survive but prosper. A well-managed QMS is paramount to success.   What is a good Quality Management System? QMS systems come in all flavors and shapes, some are industry specific, others more general,...
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Approval Workflows in QMS

Approval Workflows in QMS

Achieving and maintaining compliance is not an easy job as both ISO and FDA regulations require that documents be approved before they are officially distributed or used either inside or outside the company. Obtaining approval from a group of people for a project plan, a proposal, or any other required document can be a frustrating...
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Documents in a Paperless Office, Find a Needle in the Haystack

Documents in a Paperless Office, Find a Needle in the Haystack

The QMS documentation – especially for a complex project – can be endless and impenetrable. All of us are familiar with the pain of trying to make order out of complete file chaos, or the vain hope of finding a particular document in a pile of paperwork, be it old-school paper based or modern electronic...
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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...
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Project management and quality management 2017 - smart solution

Project management and quality management 2017 - smart solution

qmsWrapper is 1 system with 5 modules   and if you thought project management couldn't include QMS... think again...    In a global environment, companies are facing countless complex and unique industry challenges. Quality becomes not just a buzzword but a true competitive advantage – companies that deliver the best quality products and services efficiently - succeed. Today’s QMS and...
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QMS Processes & ISO Compliance (ISO compliance in the business world and QMS processes)

QMS Processes & ISO Compliance (ISO compliance in the business world and QMS processes)

In a global environment, companies are facing countless complex, unique industry challenges. Quality becomes not just a buzzword but a true competitive advantage – companies that deliver the best quality products and services efficiently - succeed.   In a global environment, companies are facing countless complex, unique industry challenges.   ISO certification, (be it ISO9001, ISO13485…)  communicates a commitment...
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6 Benefits of ISO Compliance

6 Benefits of ISO Compliance

ISO’s standards are created to guide companies in dealing with some of the most demanding challenges of modern business – Quality & Customers. At its core, the ISO system is underpinned by the pursuit of recognizable quality that ties business goals and customer needs. The aim is to make business operations as efficient as possible...
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