Medical Device Design and Development | Combination Products | Design Control

cGMP Expectations for Drug-led versus Device-led Combination ProductsПодробнее

Post-Market Surveillance for Medical Devices & Combination ProductsПодробнее

Beyond Design Controls 101: Following the Regulation vs. Understanding its IntentПодробнее

LTR 28: It is time to build equity in medical device design controlПодробнее

The Combination Products HandbookПодробнее

Drug Device Combination products certificate for medical devicesПодробнее

US Drug Delivery Combination Product RegulatoryПодробнее

Combination products: regulatory approach and cGMP requirementsПодробнее

Creating a New Mind Set for Combination Product DevelopmentПодробнее

Design History File Consultant - Operon StrategistПодробнее

Combination Products: Successful Product Development and Regulatory Anticipations and ComplexitiesПодробнее

Why Design Validation is More Than Testing: How to validate your validationПодробнее

Design Control for Pharmaceutical Combination ProductsПодробнее

Human Factors Engineering in Medical Products Reviews (2of14) REdI 2018Подробнее

Generic Combination Products: Assessment and Regulatory Update (14of16) GDF 2020Подробнее

Panel Discussion - Drug/Device Combination Products Summit 2018 by QeplerПодробнее

Drug/Device Combination Products Design & Development SummitПодробнее

CGMPs for Combination Products: Understanding and Applying FDA’s Draft Guidance - Barr Weiner of FDAПодробнее