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regulation

MedTech Europe has said it remains held back by “slow and piecemeal implementation” of the new IVDR and MDR framework. Read more

News

The MHRA has reiterated guidance on how medical devices will be regulated in the event of a no deal Brexit. Read more

News

The editors of Medical Plastics News and Med-Tech Innovation News want to know if you are ready for the enforcement of these regulations. Read more

News

Failing to maintain regulatory alignment with the European Union could mean that the UK could be part of fewer, if not excluded, from clinical trials, according to Professor Tamara Hervey from the University of Sheffield. Read more

Features

Disruptive technologies have the potential to make improvements regarding both disparities and discrimination, according to Professor Nicolas Terry from the University of Indiana. Read more

Features

Web content editor Ian Bolland visited the University of Manchester’s Healthcare Disparities: Disruptive Healthcare Technologies and the Patient Event. Here, he highlights two key points brought about from two days of lectures. Read more

Features

As part of the research for the report, “Electronic Skin Patches 2019-2029” IDTechExResearch has characterised some of the regulatory considerations in the context of each of the product sectors covered. Read more

News

Patient Guard Limited was established in 2017, with the intention of being the partner of choice for medical device manufacturers, on being compliant with medical device regulations and quality assurance requirements. Read more

Expo News

Manufacturers need to set a clear roadmap to compliant clinical evaluation reports, says David Egbosimba, solutions delivery manager, Maetrics. Read more

Features

Maik Endler, Knoell Germany, examines the challenges for start-ups gaining medical device approval. Read more

Features

Brian Moan, director of Solutions Delivery Europe and Norm Rabin, director of Solutions Delivery at Maetrics write about what to expect from the new IVDR regulatory framework. Read more

News

Paul Bulteel, partner at life sciences executive search firm the RSA Group, discusses why the medtech industry needs new talent to help navigate regulatory changes and enable market access for medical devices. Read more

News

On day one of Med-Tech Innovation Expo, Ken Block, president and founder of Ken block Consulting will discuss recent drafts and final FDA guidance on a variety of topics. Read more

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Antoine Baschiera, CEO of Early Metrics, the rating agency for start-ups and SMEs, looks at the future trends expected to hit medtech. Read more

Features

Exhibitors attending the Med-Tech Innovation Expo share their views on Brexit, sector expectations, key initiatives and more in this insightful interview into the medtech industry. Read more

Expo News

Component supplier Reliance Precision has announced that it has now received ISO 13485 certification. The certification will allow the company to further develop its medical and life sciences business. Read more

News

The BSI’s UK & Ireland Medical Devices Regulatory Seminars in November are for all medical device manufacturers, regulatory affairs and quality assurance staff. Read more

News

Global public health and safety organisation NSF International recently completed the acquisition of Prosystem, a German medical device consulting firm specialising in regulatory affairs and clinical evaluation. Read more

News

The British Standards Institution (BSI) tells Med-Tech Innovation why it developed Compliance Navigator – a workflow tool that takes the leg-work out of managing medical compliance. Read more

Features

Finnish cross-platform development company announces plans to work with the medical device sector. Read more

News