Global healthcare systems are under significant strain to deliver improved, cost-efficient care. The shift away from fee-for-service towards value-based models, which tie reimbursement to quality, has intensified this need. Certainly the medical device sector needs to go under...

It's a no brainer really. If your business designs and develops software products, then core delivery teams should continuously monitor the net quality of such a product. Yet, some organisations or businesses make little progress regarding quality management and continuous improvement.

The UK grace period comes to an end on the 1st January 2022 and I have had numerous conversations regarding Medical Devices to be placed on the UK Market after Brexit by popular demand. Many manufacturers based in the EU27-market (EU27) face similar scenarios and are scratchin...

There is a crackle in the air. EU MDR is now applicable and internationally obliged. Over the last two years, there has been a steady MDD to MDR transition. Generally, the MDR has been a welcomed advancement for us in Regulatory, Quality x Legal affairs, but there remain proc...

It may be said with some certainty that last year many gradually slipped into insanity. The timing could not have been worse for multiple industries which scrambled to find alternative measures to counter the irregular pandemic. Europe and the UK have been economically inferti...

Tectonic technological shifts often cause great change or dissatisfaction. People either identify directly with technological change or naturally take a more conservative stance. By and large, however, the Life Sciences and the Healthcare sector have both seen a tremendous amo...

We are humans before we are users. Every human on earth is wired differently. To that effect, every human uses software differently. They may follow the same breadcrumb trail, weaving through different window panes of a given GUI but in between something else happens. It is so...