MDSAP, the Medical Device Single Audit Program, has existed since the beginning of 2018. This seminar will help you to understand the concepts of MDSAP and to meet the requirements safely and with minimal effort.
Background:
As of January 2019, manufacturers will need an MDSAP audit so that they can export their medical devices to Canada.
As part of this training, you will learn which requirements you and your company must know, understand and meet.
Objectives Contents of the seminar- Background and history of MDSAP
The basics of MDSAP: How did MDSAP come about and which countries take part. - Concept and applicability of MDSAP
You understand the concept of MDSAP and the interaction between authorities, certification organizations and your company. You will learn which authority audits can be replaced by an MDSAP audit. - Requirements in the MDSAP audit
Here you get to know the requirements in MDSAP audits. Which country-specific requirements are applicable? When and in which cases do these country-specific requirements apply to you? - Procedure for MDSAP audits
The procedure for MDSAP audits is different from the previous audits according to ISO 13485 and Directive 93/42. We explain the differences and what to look out for when preparing for an audit. - Preparation for an MDSAP audit
The questionnaires of the certifying organizations multiply in scope. We (more) clarify terms and the questionnaires of the certifying organizations using an example. - Audit sequence and questions in MDSAP audits
The audit structure of MDSAP audits is also specified, as is the questionnaire. Here you will learn which questions the auditor will ask and what effects the audit structure has on the course of the audit. - Deviations in MDSAP audits
There are not only major and minor deviations, but fixed rules for the gradation of deviations. The consequences of when follow-up audits are required and which deviations are reported directly to the authorities are explained. - Implementation of requirements using the example of Health Canada.
How can you best implement the country-specific requirements? Using the example of the requirements of Health Canada, we will show you how you can implement the requirements in a simple and lean way.
This seminar gives you a comprehensive understanding of the procedure for MDSAP audits and the ability to prepare specifically for an MDSAP audit. You know how to revise your quality management system, especially your processes and specification documents, in order to implement the country-specific requirements that are checked in MDSAP audits.
Here you will find further information on the next dates , costs and registration . Unless otherwise noted in the table on the overview page, there are still vacancies .
KONTAKT:
Online Seminar