Automation

Advantages of Workflow Automation in Healthcare: Minimizing Administrative Burden and Enhancing Compliance

By Ben Manning

…dissatisfaction, often at competitively reduced rates, adds to the complication of staff hiring and retention. Digitized workflows that merely replicate paper-based processes contribute to these inefficiencies. These digital workflows often…

…dissatisfaction, often at competitively reduced rates, adds to the complication of staff hiring and retention. Digitized workflows that merely replicate paper-based processes contribute to these inefficiencies. These digital workflows often…

Continue reading

LDT Development

The FDA’s final lab developed test rule places new burdens on manufacturers

By Laura Housman

compliance. Diagnostics Industry: This industry has the potential to benefit from clearer commercialization pathways, opening avenues for innovation. However, companies in the development and commercialization of LDTs will need to…

compliance. Diagnostics Industry: This industry has the potential to benefit from clearer commercialization pathways, opening avenues for innovation. However, companies in the development and commercialization of LDTs will need to…

Continue reading

Smith+Nephew logo

Smith & Nephew shares surge on activist Cevian building stake

By MedTech Intelligence Staff

…to reports by Reuters. According to LSEG data, Cervian is known for taking stakes in companies and calling for change. In recent years, Smith & Nephew has lost significant stock…

…to reports by Reuters. According to LSEG data, Cervian is known for taking stakes in companies and calling for change. In recent years, Smith & Nephew has lost significant stock…

Continue reading

Regulatory Survey 2024

SURVEY: Managing global regulatory strategy and compliance ā€“ assessing status, gaps, and needs.

By Celegence, MedTech Intelligence Staff

…regulatory competencies and resource availability due to increasing complexity and changing compliance requirements. Regulatory Fatigue…are we there yet? The April 2024 survey among medical device companies illustrates an industry rapidly…

…regulatory competencies and resource availability due to increasing complexity and changing compliance requirements. Regulatory Fatigue…are we there yet? The April 2024 survey among medical device companies illustrates an industry rapidly…

Continue reading

FDA

FDA publishes long-awaited clinical trial diversity guidance

By Hogan Lovells Engage

…26. The draft guidance states that compliance with the DAP initiative will not come into effect until 180 days after the future final guidance is published. Even so, sponsors should…

…26. The draft guidance states that compliance with the DAP initiative will not come into effect until 180 days after the future final guidance is published. Even so, sponsors should…

Continue reading

Thermal Solutions

Advanced Thermal Solutions in OEM Medical Device Design

By Andy Selvy

…medical devices brings a set of complex challenges that must be carefully managed. Ensuring safety and compliance is paramount, as medical devices are some of the most heavily regulated products…

…medical devices brings a set of complex challenges that must be carefully managed. Ensuring safety and compliance is paramount, as medical devices are some of the most heavily regulated products…

Continue reading

EU Commission

The impacts of the EU Data Act on medical and health devicesā€™ companies

By Anne-Gabrielle Haie, Maria Avramidou

…required to comply with the EU Data Act, medical and health devices’ companies would do well to already commence assessing what they will need to do to comply with it….

…required to comply with the EU Data Act, medical and health devices’ companies would do well to already commence assessing what they will need to do to comply with it….

Continue reading