Smridula Hariharan
Smridula Hariharan

Ask the Expert: PMCF implementation under EU MDR

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).

Continue reading

Dhirti Roy
Dhirti Roy

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

By MTI Marketing Staff

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.

Continue reading

Evidence Partners
Evidence Partners

How Literature Review Automation Improves CER and PER Program Management

By Marc Dufresne

Beyond simply allowing for broader yet more efficient searches, leveraging software to automate literature reviews can organize references, assign screeners, and review screening decisions. This saves time, reduces bottlenecks, and, most importantly, leads to a highly transparent, standardized, and repeatable process that supports continuous CER and PER submissions across a product portfolio and for the life of a device.

Continue reading