Einzelschulung
Sonstige
Exam for AISP
Vor Ort / Virtuelle Schulung
Weiter: 24. September 2026
German / Englisch
Schulungs-ID: 167910204
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Auf Anfrage
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16 hours
Online
ISO 13485 MD QMS Lead Implementer Self-Study Training Course (PECB)
ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices.CertificationAfter successfully passing the exam, you can apply for one of the following credentials shown. You will receive a certificate once you comply with all the requirements related to the selected credential. PECB Certified ISO 13485 Provisional ImplementerPECB Certified ISO 13485 ImplementerPECB Certified ISO 13485 Lead ImplementerPECB Certified ISO 13485 Senior Lead ImplementerEnrolment informationBy enrolling on this course you agree to your personal information being passed to PECB.Learners enrolling onto this course will receive an email from PECB to set up your Learner Account, course registration, access to the course materials and final exam.If you have not received this information within 5 working days please contact Global.PECB.Training@sgs.comGeneral informationPECB will provide over 500 pages of instructional materials containing explanations, guidance, and practical examples. Learners may reach out to PECB to request the Attestation of Course Completion as proof of taking the course, this can be requested before taking the exam or after and is worth 16 CPD (Continuing Professional Development) credits.In case of exam failure, the candidate can retake the exam once for free within 12 months following the initial exam date.PrerequisitesA fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.The fee for this course covers:Course Materials (for lifetime, please note that updated course materials are not included)First ExamOne resit exam (if required)PECB Certification FeeFirst Year PECB Annual Maintenance Fee (AMF)
925,00 €
exkl. MwSt. (EUR)
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725,00 €
exkl. MwSt. (EUR)
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