Two QA/RA experts highlight hot-button topics that quality assurance and regulatory affairs professionals should keep an eye on in the medtech space this year.
There are probably a million and one things quality assurance and regulatory affairs professionals should keep a sharp eye on in the medtech space this year.
But to keep things simple, Medtech Insight has pared that list down to four of 2021’s hottest quality and regulatory topics.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.
The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
