Faced with the looming deadline for compliance of May 2020, many medical device companies still haven’t fully grasped the impact of the new EU Medical Device Regulations (MDR) across all their product labelling. The requirements also affect what goes on Information-for-Use (IFU) leaflets and electronic equivalents. Here, Graham Francis offers…
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The current regulatory system for medical devices in the UK, as an EU member state, is complex enough without the uncertainties surrounding Brexit. In this article, legal advisor Paul Ranson reviews the current and forthcoming regimes and how Brexit may impact manufacturers and regulators working in this space.
A recent industry report projects a boom in the biosimilars market over the next three years and highlights key considerations for meeting its potential.
Barely larger than a smartphone, the Mira P is one of the fastest and most compact Raman spectrometers on the market. With the Mira P, you will get accurate results in just seconds.
On-demand webinar: Leveraging Data Management for Root Cause Identification in Critical Environments
With the increasing employment of sophisticated Data Management software, the collection and evaluation of multiple data has never been easier! However, managing such a large amount of information may represent a challenge, resulting in a potential obstacle to effective identification of the root cause of the environmental OOS associated deviation…
Release of parental drugs for injection requires test apparatus to be accurate, precise, reliable and compliant with the latest international regulation.
A team has developed a microrobot that is effective at targeting specific areas, so could be used in hyperthermia therapies when treating cancers.
How to implement the Industry 4.0 program as a part of your automation strategy.
Positron emission tomography (PET) is a popular nuclear imaging technique used to gain information about specific metabolic functions.
SGS Life Sciences offers tailored study design and testing for extractables and leachables (E&L) in finished pharmaceutical packaging, process equipment and medical devices, and leachables in final product for clients using single-use systems (SUS).
The purpose of this Position Paper is to consider the scientific basis for accelerating extractables and/or leachables studies via the proper combination of contact temperature and duration (time). Considering this scientific basis, recommendations concerning proper acceleration strategies are provided.
The MiniCapt Mobile Microbial Air Sampler allows the user to perform viable air sampling in cleanroom environments for classification and monitoring purposes.
PharmaIntegrity™ is the definitive solution for managing the collection, analysis, and trending of environmental monitoring data, ensuring timely detection of problems in production, facilitating product release and reducing risks and costs associated with product loss and recalls.
The global pharmaceutical robots market is set to be worth $344.4m at the end of a forecast period, after seeing substantial growth.