Design and Development Requirements for Medical Devices Training
COURSE OUTLINE The FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016 and Medical Device Single Audit Program (MDSAP)…
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ISO 14971:2019 Application of Risk Management to Medical Devices Training
COURSE OUTLINE Practical workshops throughout the day are also provided in order to give you the opportunity to apply your…
Medical Device Single Audit Program (MDSAP) Fundamentals and Readiness Training Course
COURSE DESCRIPTION The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to meet regulatory and quality system requirements…
Medical Device Regulation (MDR 2017/745) Training Course
COURSE DESCRIPTION Implementation of European Medical Device Regulations is the primary requirements while demonstrating the compliance to regulatory requirements while…
AMDD & Common Submission Dossier Template Preparation Training course
AGENDA DAY ONE Morning Session 09:00 – 09:30 Module 1: Overview of Worldwide Medical Device Regulations (United States,…
Corrective and Preventive Action
COURSE OUTLINE This 1 day special training course “Corrective and Preventive Action” is intended as an introductory course to enable…
Quality System Regulations (21 CFR Part 820) Training
COURSE OUTLINE This 1 day special Quality System Regulation training program is intended as an introductory course to enable participants…
Process Validation Training
COURSE OUTLINE Due to the complexity of today’s medical products, routine end-product testing alone is often not sufficient to assure…
ISO 13485:2016 Requirements & Internal Audit Training
COURSE OUTLINE ISO 13485:2016 an international standard designed to orient quality management systems toward the design, development, production, and installation…