Captis Ask the Expert

AI and Automation Tools: Medical Writers’ Point of View

By Celegence
Captis Ask the Expert

EU MDR and IVDR have created many new challenges for medical writing and regulatory affairs professionals. An increased workload, combined with the scarcity of expert resources, makes it essential to find innovative solutions that maintain efficiency and prevent burnout among highly skilled teams. How does use of technology help? AI-driven tools and automations enhance productivity,…

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Smridula Hariharan

Ask the Expert: PMCF implementation under EU MDR

By MTI Marketing Staff
Smridula Hariharan

Smridula Hariharan leads a team of medical writers who work on CEPs, CERs, PMS Plan, Post-Market Surveillance Reports, Periodic Safety Update Reports, Post-Market Clinical Follow-up Plan and Reports, for devices spanning a wide range of therapeutic areas. Here, she shares secrets to cost-effective PMCF strategies in the dynamic landscape of the European Medical Device Regulation (MDR).

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Dhirti Roy

Ask the Expert: What is Regulatory Excellence in the Medical Technology World?

By MTI Marketing Staff
Dhirti Roy

Regulatory excellence is now considered a pathway to innovation and sustained business growth, making it a fundamental component of success in the medical devices industry. MedTech manufacturers are fostering a culture of regulatory excellence to enhance compliance with regulatory requirements and ensure product safety, efficacy, and quality in the global marketplace.

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