Tecan uses cookies to improve our website. By continuing to browse our website, you accept our cookie policy.


The Blog

Selected category: Quality, Compliance & Regulatory

Back to overview

Survive or thrive? IVDR for laboratory developed tests in mass-spectrometry

By Magali Wolff

You could say that the road to in vitro diagnostic medical devices regulation (IVDR) implementation has been rocky. We have read all of the documents, spent hours in meetings and felt our heart stop with every new announcement about...

Read more

Achieving IVDR certification that meets EU regulation in 2022

By Günter Weisshaar

The announcement of the In Vitro Diagnostics Regulation (IVDR) in 2017 was celebrated as an essential upgrade to in vitro diagnostic (IVD) device regulations in Europe. This article discusses the important changes, challenges,...

Read more

Five secrets to a successful IVD OEM partnership

By Nicholas Smith

You are considering an Original Equipment Manufacturing (OEM) partner to support you in bringing your idea to market. The planned in vitro diagnostic device may require components, robotics and modules. You may need integration...

Read more

Mind the gap: How to navigate the IVDD-IVDR transition – Part 2

By Laura Nea

The global trend toward more stringent regulatory control of in vitro diagnostic (IVD) medical devices is sending shock waves through the industry. Now that we have passed the halfway mark in the transition to Europe’s new In Vitro...

Read more

Mind the gap: How to navigate the IVDD-IVDR transition – Part 1

By Laura Nea

Is your business IVDR-ready, or are there treacherous gaps in your strategy? This November marks the halfway point in the five-year transition to the In Vitro Diagnostic Regulation (IVDR) 2017/746—a major regulatory overhaul that calls...

Read more

ISO Standards for automated liquid handling systems – what labs need to know

By Markus Wiggli (in collaboration with Artel)

Imagine discovering that one of your company’s core liquid handling procedures has been generating variable results from one automation platform to the next, or one lab to the next. The impact could...

Read more

Lessons of the pandemic: 3 ways to secure lab operations

By Dr Beatrice Marg-Haufe

The COVID-19 pandemic has forced everyone to look at laboratory routines to see if they are really pandemic proof. For example, the explosive demand for high throughput genomic analysis often creates pressures upstream to...

Read more

Pandemic preparedness: Scaling up for the healthcare industry

By Joe Rotter

How do you prepare for the unexpected? The COVID-19 pandemic has brought to light how challenging it is for labs and production facilities to scale up quickly in times of need. The sudden surge in demand for laboratory solutions at the...

Read more

For data reproducibility: automation of ELISA test kit protocols wins

By Magali Fischer

Automating robust assays is a way forward

Generating reproducible, accurate ELISA data starts with reliable reagents that are highly sensitive and specific. These are often available as kits that need to be incorporated into an...

Read more

Getting to the root of poor ELISA data reproducibility

By Magali Fischer

With more than 50% of preclinical results estimated to be irreproducible, the reliability of methods, assays, and protocols is a major concern in all areas of research. Many critical assay workflows, such as those for ELISA tests,...

Read more

Why outsourcing lab automation solutions is more cost-effective than you think

By Nicholas Smith

It can be easy to dismiss outsourcing lab automation in favour of seemingly less expensive do-it-yourself (DIY) solutions. However, outsourcing is more cost effective than it might seem. By taking advantage of the expertise of...

Read more

Liquid Handling 4.0: what to consider when selecting OEM robotic components

By Claudio Bui

Lab automation and liquid handling solutions are evolving rapidly, shaped by many of the same forces and disruptive technologies that define the fourth industrial revolution. Alongside Industry 4.0, you could say that the era of...

Read more

Pumping blood: choosing a liquid handling pump for hematology applications

By David Wold

Today’s hematology labs are faced with escalating demands to deliver robust and accurate blood test results quickly. At the heart of automated diagnostic systems for blood analysis are liquid handling pumps, which must deliver precise...

Read more

Liquid handling pump selection: a guide for lab automation engineers

By David Wold

From the perspective of a lab automation systems engineer, specifying the optimal liquid handling pump and associated fluidic components is often central to the design process, especially for products that will be used in a clinical...

Read more

Five essential software questions to ask before buying a liquid handling instrument

By Hal Wehrenberg

All automation is controlled by software and understanding the differences between options can be complicated. Underestimating the impact of software may set back your budget or critical timelines.

Read more

Seeking powerful analytics to improve lab procurement? Here’s what to look for

By Severin Heynen

Improving lab procurement processes involves more than just putting e-procurement or lab management software in place. In most cases accessing, managing and analyzing the data that you use to support purchase decisions and feed...

Read more

How to secure long-term performance of OEM components for automated liquid handling

By Claudio Bui

When you design a complex laboratory automation system or device, every OEM liquid handling component that you integrate into it should be reliable, dependable and expected to perform to the highest industry standards. Subpar quality...

Read more

11 key points to install and efficiently initiate a new automated assay system in your laboratory

By Hal Wehrenberg

Congratulations. It took you quite some time and effort to convince your management or institution on the value of investing in automating your experimental or clinical workflow. The applications were submitted, the presentations...

Read more

Six tips to help match your liquid handling components with chemical compatibility

By Claudio Bui

The demand for advanced medical and diagnostic testing continues to accelerate. Laboratories, hospitals, and emerging consumer genomics companies are demanding quicker test sequences resulting in the design and development of new...

Read more

Five ways instrument utilization data can boost your lab’s efficiency

By Michelle Aichele

Are you guilty of making decisions without the data to back them up? In today’s busy labs, mission-critical decisions about laboratory equipment purchases, service contract renewals, consumables spending, and staffing are often...

Read more

Is what you don’t know costing you? Why instrument utilization data could be your lab’s biggest asset

By Michelle Aichele

As we move into the 2019 budget cycle with signs of a global economic slowdown on the horizon, laboratory administrators are no doubt feeling the heat. A combination of poor forecasting, inefficient use of resources, and a sudden...

Read more

Liquid handling in a regulated lab: 5 automation must-haves

By Hal Wehrenberg

Cost-efficient application of advanced technologies such as next generation sequencing (NGS) and liquid-chromatography/mass spectrometry (LC-MS) demands sophisticated automation solutions that can handle complex protocols and...

Read more

Six questions to ask before choosing liquid handling robotic components for faster time to market

By Claudio Bui

When introducing a new product to the automated liquid handling market, getting there first with high quality and reliable hardware is vital to capturing and maintaining early market leadership. How can you gain that advantage when...

Read more

7 secrets for success when automating NGS for clinical diagnostics

By Alexandra Sommer

Rapid advances in molecular diagnostics, including the application of advanced methods such as next generation sequencing (NGS) in clinical diagnostics, are revolutionizing healthcare. But this puts a lot of pressure on clinical...

Read more

How to make your genomics research more reproducible

By Kevin Moore

The repeatability of biomedical research has become a major issue, and the ability to achieve reproducible research results can only be as good as the liquid handling performance. Automation has become a given step in the drive to...

Read more

Make versus buy strategy:  Why, when, and how to use a liquid handling OEM components partner

By Claudio Bui

When designing products that include automated liquid handling, how do you decide when and what to buy from an OEM components supplier vs. designing in-house? How do you then decide who will be the right partner for you? A...

Read more

Drowning in data: Can precision medicine get smart enough, fast enough?

By Nicholas Smith

Cognitive computing and artificial intelligence have the power to save us from drowning in the vast and growing sea of data needed for precision medicine, but what will it take to achieve a timely return on investment? Experts from...

Read more

Struggling to balance GxP compliance and productivity? Not all automation platforms are created equal

By Jason Meredith

In an increasingly regulated industry, clinical laboratories and manufacturers of in vitro diagnostic (IVD) tests are feeling the pressure to ensure regulatory compliance, while at the same time striving to increase productivity...

Read more

Why automation of laboratory developed tests is key to easing regulatory compliance

By Jason Meredith

Hospitals are becoming the new centers of innovation for novel clinical diagnostic tests. While this is enabling more sophisticated and personalized approaches to disease prevention, early diagnosis, and targeted treatment, it also...

Read more

Achieve validation faster – integrate Tecan IQ/OQ validated tips into your automated liquid handling solution

By Severin Heynen

As we have seen in the previous posts in this series, developing validated analytical methods becomes more cost- and time-effective when solutions with guaranteed compatibility are incorporated into the analytical system. 

Read more

Make your lab work flow with Fluent ID™

By Florence Collins

A long-term clinical lab study lasting over 10 years showed that more than 60% of all mistakes in the stat lab (the lab that receives high priority samples) can be attributed to the pre-analytical phase. This figure has not...

Read more

Using integrated solutions to efficiently meet regulatory demands

By Severin Heynen

Well-documented reliable, accurate data that meets regulatory demands is crucial for success The key is to develop robust analytical methods based on instruments and other components that perform well together to ease the way...

Read more

The regulation of lab developed tests: an uncertain future

By Nicholas Smith

If the U.S. Food and Drug Administration (FDA) goes forward with its proposed guidance to regulate laboratory developed tests (LDTs) in the same way it does manufacturer-derived tests, then much is going to change for clinical...

Read more

How automated test tube barcoding adds reliability and stops unnecessary errors

By Florence Collins

Scinomix, Inc., founded in 2001, creates customized solutions for labeling tubes, vials and plates in many life science applications. We took the chance to ask Nigel Malterer (CEO) and Jonathan King (Automation Software Engineer)...

Read more

The regulation of lab developed tests: How not to inhibit advances in personalized medicine

By Nicholas Smith

The intention by the U.S. Food and Drug Administration (FDA) to issue a new guidance that would bring oversight of laboratory developed tests (LDTs) directly under FDA regulatory control, instead of the current paradigm in which...

Read more

Navigating the Future of Laboratory Developed Tests - The Impact of New FDA Guidance

By Nicholas Smith

Uncertainty and concern best describe the prevailing feelings of many researchers, clinicians, and companies that develop, manufacture, and implement laboratory developed tests (LDTs). The reason for all this uncertainty is the...

Read more

Standardized verification of pipetting performance is key to efficiency and regulatory compliance

By Agnieszka Sitarska

Whatever you are using automated liquid handling for, be it drug development, next generation sequencing, assay development or basic research with cell-based assays, getting correct results is crucial to reaching your goals,...

Read more

How to make the right choice for barcoding sample tubes

By Florence Collins

Barcodes play a central role in minimizing the risk of error in lab automation by providing secure tracking of components throughout the workflow. Barcode-guided lab automation can be simple and cost-effective, with significant...

Read more

The importance of liquid handling QC in an automated lab

By Kevin Moore

Dana Campbell, Field Support Specialist, Artel, considers the importance of quality control (QC) from an applications perspective.

Read more

The economics of robotics

By Martin Braendle

Robotics and automation have become essential to the future plans of drug discovery and clinical diagnostic companies. Executives are looking to increase productivity and reduce costs, and automation fits the bill in every respect.

Read more

Lab developed tests and FDA regulations in the IVD market

By Nicholas Smith

Today there is much discussion on the Food and Drug Administration (FDA) regulation and oversight of Laboratory Developed Tests (LDTs). The debate features numerous topics including the necessity for regulation, whether the FDA has...

Read more