An NSF International Company M7 - Working with Regulatory Agencies - Pre Market Technical Briefings for Medical Devices (QP)
PrintPart of Medical Devices QP Training Module 7
£1740.00 exl VAT
About this course
A two day course aimed towards medical device manufacturers or manufacturers unsure of the appropriate regulatory classification. This course has been developed in order to help you understand the regulatory agencies involved in formulating a medical device classification when it is extremely complex, novel or has borderline properties. The course helps you to prepare technical information in a way that can be presented to regulatory agencies so that you can achieve definitive responses as to the classification, conformity assessment route and need for pre-clinical and clinical data. The course begins by describing the importance of the product description, intended use and principal mode of action. From determining who to contact in what agency through to simple tips for managing the briefing, you will find this course invaluable if you wish to carve out a career in advanced regulatory, quality or product safety in healthcare technology products.
Who Should Attend
The course is aimed at personnel within the organization involved specifically with scientific and/or regulatory affairs strategic planning and regulatory enforcement. In a world where regulatory scrutiny has increased several-fold it is crucial that professionals are capable of communicating effectively with their regulatory agency at pre-clinical, pre-submission, submission and regulatory enforcement phases. The course also provides excellent guidance upon responding to regulatory agencies during times of business critical enforcement.
