Tag Archives: Ask the Expert

Smridula Hariharan

Ask the Expert: PMCF implementation under EU MDR

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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Dhirti Roy

Ask the Expert: Benefits and Challenges of the eStar Submission Process

Dhirti Roy

Companies must now electronically submit all FDA 510(k) submissions using the eSTAR platform. Dr. Dhriti Roy, vice president of Regulatory Affairs Transformation at Essenvia and faculty at Oxford University’s MedTech innovation platform, highlights the benefits and challenges of eSTAR, as well as processes and tools companies need to adopt as they transition to this new submission process.

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Doug Donahue

Ask the Expert: Four Key Reasons Medical Device Manufacturers Should Be Looking at Mexico

Doug Donahue

The growth of the medical device industry brings increased competition and a need to find ways to become more efficient and cost-competitive, without compromising quality. In this column, Doug Donahue, Director of Foreign Direct Investment and Manufacturing for Guanajuato’s Medical Device Cluster and co-managing partner of Entrada Group, discusses the benefits, challenges and opportunities available for companies investigating Mexico as a manufacturing site.

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Wiktoria Banczyk
MEDdesign

Ask the Expert: The Impact of IVD Regulations on Manufacturing

Wiktoria Banczyk

IVDR has significant implications for the manufacturing of IVD devices, as it requires manufacturers to comply with new and more rigorous regulatory requirements. Wiktoria Banczyk, Product Manager Lab Filtration Medical Devices at Sartorius Lab Instruments, discusses the challenges posed by the implementation of EU IVDR 2017/746 and key considerations for manufacturers as they navigate today’s regulatory landscape.

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