Fritextsökning
Innehållstyper
-
FDA’s new CSA guidance: transforming software validation for production and quality systems
FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System Software marks a significant modernization of software validation practices.
-
IVDR Reality Check: Are We Moving Fast Enough?
As of February 2025, around 1,500 IVDR certificates have been issued. But if an estimated 18,700 devices still need certification before the 2029 deadline, then...
-
New version of ISO 10993-1: the core standard for the biological evaluation of medical devices
ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International St...
-
The FDA’s new transparency policy (Part 2)
In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...
-
The FDA’s new transparency policy (Part 3)
As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness a...
-
Quality assurance for research and development of medical devices
Overcome the hurdles of research, development, and QA lab environments within the regulated medical technology industry.
-
Quality solutions for medical device R&D applications
From R&D to the quality assurance of series production in medical device manufacturing.
-
After the threat of tariffs – Novartis invests 230 billion in the USA
Pharmaceutical giant Novartis plans to invest 23 billion dollarsover the next five years to expand its production in the USA. The goal is for all medicines dest...
-
Korbinian Löbmann leads scientific meeting on drug formulation: High activity in the field
Korbinian Löbmann has moderated New Updates in Drug Formulation & Bioavailability several times before. Now he is once again taking on the scientific meeting. L...
-
ZEISS Lightfield 4D for instant volumetric high-speed imaging
Capturing physiological and neuronal processes in 3D.
-
Pneumatics Makes a Technological Leap with Piezo
The first high-precision proportional valve terminal VTEP opens up new application areas
-
Life science trends 2025 – Neurology
New Alzheimer's drugs are beginning to be used in Sweden, more deals in the neuro sector are expected, and tools for deliver active substances across the blood-...
-
Automated dispensing
Are you interested in automated dispensing of liquids?
-
Pneumatics Makes a Technological Leap with Piezo
The first high-precision proportional valve terminal VTEP opens up new application areas
-
Large study on milk: Risky for women but not for men
The risk of ischemic heart disease (IHD) and acute myocardial infarction (MI) increased for women with milk intake levels higher than 2 glasses per day, while n...
-
Automated dispensing of a viscous hydrogel
A suitable solution developed for UPM Biomedicals In the Festo LifeTech Application Center we tested a setup for UPM Biomedicals for the automatic dispensing of...
-
Cost-efficient development of laboratory devices
8 ways to optimise development costs and speed up processes
-
Extremely high sample throughput rates
Precision and reliability in automated liquid handling
-
Easy integration of piezo valves for gas handling
Extremely energy-saving, silent and without any heat build-up – piezo technology offers many benefits for efficient and precise gas handling in medical technolo...
-
The first Lyme disease vaccine faces a delay
Pfizer and Valneva’s Lyme disease vaccine, which could be the first of its kind, is facing delays of about a year. The reason is problems at trial sites in the ...
-
Lucy Robertshaw: Artificial intelligence – is this really going to transform a patient’s life?
In a column Lucy Robertshaw reflects on how AI and new regulations will affect healthcare, innovation and the lives of future patients.
-
Efficient use of blood plasma
Blood plasma is an indispensable resource in the production of life-saving medicines. It is in high demand on global markets. To make more efficient use of this...
-
AI baserad på språkalgoritm skapade nya fungerande proteiner
Inte ens proteiner går säkra för språkrobotarna. I det senaste numret av Nature Biotechnology presenterades språkmodellen Progen som, enligt forskarna bakom stu...
-
Study names with an attitude – more important than you might think
Ironman, T-rex, Star-Trek. Popcorn, Proper, Scout. Nope, these are neither fantasy films nor dog names. They’re the names of ongoing cancer studies in Sweden.
BREAKING