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ISO certifies Wasdell Ireland facility for medical device manufacturing

Wasdell Ireland facility has been certified ISO 13485 for medical devices

Merck provides pre-seed funding to nanosyringe start up

The start up is engineering ‘nanosyringes’, a selective non-viral peptide and protein delivery system identified in an undisclosed organism

Status update on ANDA for generic Advair Diskus (VR315 [US])

Vectura Group, an industry leading inhalation CDMO, confirms the announcement made by its partner Hikma Pharmaceuticals

On your UKCA mark, get set, go!

The world of medical device regulation has undergone unprecedented change in recent years. The impact of Brexit has added to this load, as manufact...

Siemens, Perceptive Engineering and PSE join continuous manufacturing initiative

The companies will each contribute a different digital manufacturing solution to CPI's Medicine Manufacturing Innovation Centre collaboration

Precision machines enable safety critical moulder to meet COVID-19 demands

To meet ongoing demand from some of its most strategic commercial safety customers, Hi-Technology Group had already invested in five new 50 tonne S...

Safety and sustainability in medical device manufacturing

Environmental sustainability is rapidly becoming a key item on the medical device manufacturer’s corporate agenda, reports George I’ons, Head of Pr...

The new regulatory world for medical devices

Establishing an effective compliance strategy now ahead of the 2022 IVDR legislation is critical — because there’s more to come

Remote working in the medical device industry

According to <i>Time</i> magazine, the COVID-19 outbreak means that working from home is “no longer a privilege, it’s a necessity"

DNV GL receives Notified Body status for Medical Devices Regulation

The Notified Body designation has been granted for all technology types

The business and patient case for drug delivery device innovation in biosimilar products

Biosimilar development in the United States is at an important juncture, reports Darren Mansell, Regulatory Affairs Manager, Owen Mumford

Refining test methods for a new generation of nasal drug products

The nasal drug product market is currently the focus of considerable research activity. Nasal sprays for local action, such as the treatment of ill...

Datwyler launches spray-coated plungers to minimise leachables

Datwyler has launched its NeoFlex plungers to help developers better protect the integrity of injectable formulations and optimise the functionalit...

The EU MDR 2021: countdown to compliance

In April 2020, when the European Parliament voted to delay the implementation of the EU’s Medical Device Regulation by a year, some medical device...

STERIS reports 9% revenue growth

“Fiscal 2020 is shaping up to be a great year,” says CEO on the latest financial report

Drug delivery device design: supporting the success of next-generation biologics

The pressure on healthcare systems caused by ageing populations, a rise in chronic conditions and, now, the pandemic, is partly being alleviated by...