An NSF International Company M16 - Combination Product Requirements - Understanding the Safety and Usefulness of a Medicinal Substance for a Medical Device
PrintPart of Medical Devices Module 16
£735.00 exl VAT
About this course
This one day course is for all product safety professionals working with CE marked medical devices with a medicinal substance. We take you through how to project plan for the regulatory approval of the medicinal substance as well as outline the typical development planning, validations and test methods required in order to provide the EMA or national competent authorities with the data necessary to consider the safety and usefulness of the medicinal substance. If you are determining the regulatory pathway for a drug/device combination you will find this course particularly useful as it demystifies the requirements and provides you with the necessary project plan to determine the steps towards CE certification of a medical device with ancillary drug action.
Who Should Attend
Engineers, managers, supervisors, scientists, technicians, and other personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of combination products will benefit from this course.
