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European Regulatory Roundup 2021: Extensive Reshaping Of Underlying Medical Device And IVD Structures
2021 witnessed a landmark event in May when the new Medical Device Regulation first applied. The medtech sector will experience a similar milestone this year with the new IVD Regulation coming into force in some four months' time. Medtech Insight reflects on the broad and complex swathe of changes that took place in 2021, putting industry under considerable pressure, and predicts no let-up this year.
Global Medtech Guidance Tracker: December 2021
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-eight documents have been posted on the tracker since its last update.
Turkish Health System Slides Into Crisis After Devaluation Of Lira
Amid delays in surgical operations caused by shortages of equipment and medtech companies demanding payment of outstanding hospital debts, a strong devaluation of the Turkish lira has put the local health care system on a crisis footing.
Global Medtech Guidance Tracker: November 2021
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-one documents have been posted on the tracker since its last update.
Global Medtech Guidance Tracker: October 2021
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-nine documents have been posted on the tracker since its last update.
US, UK, Canada Agree On Good Machine Learning Practices
The principals recommended by the three countries could be the foundation for how their regulatory bodies intend to regulate future AI/ML products.
Market Intel: Lessons Learned From COVID-19: A Global Perspective On Digital Health Transformation
Health leaders in Sweden, Norway, Australia, Canada and Taiwan predicted the universal impact of digital solutions during the pandemic and lessons learned that will impact future care.
Global Medtech Guidance Tracker: September 2021
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
Global Medtech Guidance Tracker: August 2021
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-nine documents have been posted on the tracker since its last update.
Global Medtech Guidance Tracker: July 2021
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-nine documents have been posted on the tracker since its last update.
Recall Of Sleep, Ventilator Devices Lead To International Patient Suits For Philips
Patients in Canada and the US are suing Philips over issues related to the company’s recent recall of CPAPs, BiPAPs, and mechanical ventilators.
MDR Makes EU ‘Much Less Attractive’ For Start-Ups, Says Medtronic EMEA Chief
The fragility of start-ups belies their value in medtech innovation, and they do not need unnecessary regulatory complications.
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