Medical Device Single Audit Program: Fundamentals - International

Niveau Comprendre Durée 2 journées de formation

Disponible pour réserver: Salle de classe virtuelle 2310€ + TVA Book your place

Gain the knowledge and skills required to successfully host a MDSAP audit within your organization. Obtain in depth knowledge about this new type of audit and how your organization is best prepared to support the completing of requirements within the allotted time.

Discover how this program differs from the traditional ISO 13485 through its regulatory audit approach, the grading of nonconformities, and handling of the audit report. This course will prepare you to host a MDSAP audit and allow you to determine if your own internal QMS processes are consistent with the requirements of the MDSAP audit mode for the jurisdictions where your products are marketed.

Upon completion of this training, delegates will be able to support their organization to maintain compliance to ISO 13485 and jurisdiction requirements in the countries engaged in the MDSAP program.

Prerequisites

Delegates will benefit from reviewing the MDSAP Companion Document and ISO 13485:2016 standard before attending this course.

Pedagogical objectives

Improve auditing skills focused on regulatory auditing
Improve competence for MDSAP internal auditors and the support needed to host a MDSAP audit
Assess your own audit models and suggest improvement
Be prepared to support an efficient MDSAP audit by your selected Auditing Organization

Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating territories and organizations expanding their market reach to jurisdictions participating in MDSAP.
Upon completion of this training, you will have the:

Knowledge to:
- Demonstrate awareness of MDSAP fundamentals
- Explain the structure and scope of the MDSAP audit program
- MDSAP audit processes and their interrelationships
- MDSAP and organizational regulatory compliance
- MDSAP reporting and nonconformity grading
- Explain the differences between MDSAP and other QMS audits
- MDSAP and auditing in the medical device industry
- ISO 13485 and ISO 14971
- Identify MDSAP documentation
Skills to:
- Prepare to host a successful MDSAP audit
- MDSAP 7 auditing process requirements
- Plan audit scopes
- Analyze data sources required during process audits
- Analyze control interactions
- Use correct jurisdictional terminology
- Course materials, provided electronically
- Letter of attestation
- Official certificate
Assessment specifics
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
Course materials including:
- Introduction to the training, detailed program and security assignments
- Course presentation, theory and activities/ role plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the activities
- Attendance sheet to be signed
This guide will give you all the necessary information.
Download our training guide: Medical Device Single Audit Program (MDSAP)
* These training modules are eligible to the subsidizing by the public institutions in France (OPCO).

**Each delegate receives a training convention after enrollment.

***Please note that for the public sessions, you have until 48h before the start of the course to confirm your enrollment. For the in-house sessions, the deadline would be of two weeks prior to the start of the course.

****Should you be in a disabled situation, please contact us and indicate what details should be taken into account.

You can contact us on training.france@bsigroup.com or 01 89 79 00 40.

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