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Finding your way through the maze of international, European, and harmonized standards for medical devices - QbD Group

Finding your way through the maze of international, European, and harmonized standards for medical devices

It is important to understand how standards are written and how their references are constructed in order to properly reference them and purchase the correct version for your use.

In this blog entry, we explain the difference between ISO and IEC standards, what harmonized standards are, and how to use the appropriate standard references in your technical documentation. We also give you a hint on how to make sure you have identified all applicable standards for your products.

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Why self-inspections or internal audits are essential for your QMS

Self-inspections or internal audits are an essential part of your QMS. In addition to determining whether your QMS meets guidelines and standards, you can benefit from them in several ways. They allow you to get to know departments better, explain to people why certain quality processes are necessary, gather useful feedback for further improvements to the QMS, and you have a tool to check your readiness for external audits.

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Compressed gases in pharmaceutical manufacturing: best practices in microbial monitoring

Compressed gases in pharmaceutical manufacturing: best practices in microbial monitoring

Compressed air and other process gases are used in a lot of different steps during pharmaceutical manufacturing. Some examples are the use of compressed air in direct contact with products to clean, aerate, or move them through the processes or the using process gases in fluid pumps that take products through the production and filling processes. Compressed gases, such as nitrogen or argon, can also be used for blanketing or to spray or coat a product. The risks associated with the use of these gases, depend on the amount and type of product contact and based on this risk assessment, a suitable monitoring plan should be in place.

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Meet QbD Ambassador and Clinical Pharmacology & Pharmacometrics project lead Thomas Van Looy

At the QbD Group, we want to take into account the opinion of our employees. Therefore, our Board of Ambassadors was elected to represent the voice of all QbD’ers, within and outside of the group. Thomas Van Looy has been elected as one of our Ambassadors for 2022. Congratulations, Thomas! As an Ambassador, he loves to share his QbD Group experiences. Want to find out more about Thomas’ #QbDream job? Then don’t miss out on the interview below.

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Catarina Cruz Family Day

Meet QbD Ambassador and Device Compliance Specialist Catarina Cruz

At QbD, we value the opinion of our employees. Therefore, QbD’s Board of Ambassadors was formed to represent the voice of all QbD’ers, across the QbD Group and across all borders. Catarina Cruz has been elected as one of our Ambassadors for 2022. Congratulations! As an Ambassador, Catarina loves to share how she experiences working at QbD. Want to find out more about her #QbDream job? Make sure to read the interview below.

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EDQM and the CEP of the future - Certificate of Suitability - Qb

EDQM and the CEP of the future 

A certificate of suitability to the monographs of the European Pharmacopoeia (CEP) issued by the EDQM is considered to replace the relevant sections in the application for marketing authorization demonstrating the quality of substances for pharmaceutical use. The inclusion of a CEP in an MAA simplifies the review process for authorities and the submission procedures for industry. However, with the upcoming changes to the EU pharmaceutical legislation, the CEP procedure may be at risk. In this blog post, we outline the possible changes in the near future.

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A Day in the Life of MD Specialist Steven

A Day in the Life of a QbD MD Specialist

Medical devices are one of QbD’s main areas of expertise. We support you from concept to launch in the full life cycle. Wondering what a day in the life of a QbD MD Specialist looks like? Let’s take a look behind the scenes!

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10 Questions for 10Y birthday boy Jeroen Verhoeven

10 Questions for ‘10Y anniversary boy’ Jeroen Verhoeven

If you know that QbD was founded 10 years ago, then it won’t come as a surprise to you that the 10Y anniversary of an employee is an EXTRA big deal to us. After QbD founder Bart (obviously), Jeroen Verhoeven is the very first employee to reach that landmark.

In order to give this news the attention it deserves, we fired 10 questions at Jeroen, one for each year he’s been with us!

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Why NK Cells are a major breakthrough in the field of ATMPs - QbD

Why NK cells are a major breakthrough in the field of ATMPs

NK cells, as part of our innate immune system, are very effective in killing different types of cells, including tumor cells. Because of these properties, they become very interesting as ATMPs for immunotherapy.

Curious about the potential of NK cells and NK-cell-based immunotherapy? Learn all about them here, including the benefits and challenges.

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