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Medication rather than COVID vaccine – What are the options?

Vaccinations against the SARS-CoV-2 virus are in full swing in all countries. Many people hope for more normality and a way back to old life. So we know that vaccination is the right way, but not everyone is open for this solution. What if a drug treatment of coronavirus disease would also work? We raise […]

The Golden Ticket to correct results

In the course of the last year a multitude of COVID tests have been developed or are in the process of being developed.  But, it is the PCR test, for the detection of SARS-CoV-2, that has been the central talking point. The classic PCR test was developed in the 1980s and was a major milestone […]

Quality – More than a seal of approval

Let’s start by asking the question: What is quality? In simplified terms, quality is the sum and/or the quality of all properties of an object, system or process. The international standard for quality management systems DIN EN ISO 9000 goes a step further and describes quality as: “The capability of a totality of inherent characteristics […]

From the MDD to the MDR – Navigating the Transitory Period

In 2017, the European Union (EU) instituted the Medical Device Regulation (MDR) as the next phase in the medical device regulatory framework in order to replace the current Medical Device Directive (MDD). The MDD has been in effect since 1993, and was devised in order to harmonize disparate laws, regulations and requirements pertaining to medical […]