Regulatory Survey
Regulatory Survey

Medical Device Regulatory Survey 2024

By Celegence, MedTech Intelligence Staff

The common theme illustrated in a recent survey among medical device regulatory professionals is the need for increased resources, expertise, and technology. The data validates industry concerns of increasing workloads and overtime hours, and how many companies are finding it hard to recruit suitable skilled regulatory associates. Medical device company RA/QA teams raise concern about deficient competencies and resource availability with increasing regulatory complexity and changing global requirements.

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Post-market surveillance
Post-market surveillance

Reliable Active Surveillance: RWE for MedTech

By Amelia Hufford, PhD, Phillip Stoltzfus

As regulatory bodies increasingly recognize the richness and value of RWE, particularly in informing the benefit-risk profile of devices from real-world environments, MedTech companies are turning to advanced analytical tools to navigate this new landscape efficiently.

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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.

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Dr. Xiaoxia Li
Dr. Xiaoxia Li

From Concept to Market: The Strategic Journey from IND to NDA

By Dr. Xiaoxia Li

The Investigational New Drug (IND) application and the New Drug Application (NDA) stages are critical milestones in drug development, but they are different applications. Developers and sponsors must understand which application requires which data and when. Here we highlight strategies, hurdles and data required for successful drug development from IND to NDA.

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Nick Recht
Nick Recht

IQ OQ PQ and Its Role in Labeling System Validation

By Nick Recht

Software validation is a critical tool used to assure the quality of device software and software automated operations, including labeling. Software validation can increase the usability and reliability of the device and label, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.

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