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PECB ISO 13485 Lead Auditor — Medical Devices

ISO 13485 compliance is required by any manufacturer, subcontractor, or distributor of medical devices targeting regulated markets (CE marking/MDR, FDA): qualified auditors are rare and highly sought after. This training covers ISO 19011 audit principles, the ISO 13485:2016 standard, ISO 14971 risk management, the requirements of the MDR 2017/745 regulation, as well as the planning, conduct, and reporting of quality management system audits. It prepares for and includes the PECB ISO 13485 Lead Auditor certification exam. Available in inter or intra-company formats. Quote & registration within 48 hours.
University · Quality, Audit & ISO Certifications

PECB ISO 13485 Lead Auditor — Medical Devices

Audit the quality systems of medical devices (ISO 13485).

CertificationIn-person & remoteMorocco & Africa
PECB ISO 13485 Lead Auditor — Medical Devices — TargetUp University Morocco & AfricaTargetUp University — Morocco & Africa
The programme

Presentation

Certification sought in the healthcare industry.

Training Objectives:

  • ISO 13485 Requirements and Regulations
  • Risk management and traceability
  • Audit methodology and conduct

Format: in-person (Morocco) and remote · inter and intra-company sessions.

TargetUp University Training

Training that helps you progress.

Practitioner trainers, active pedagogy, and support until certification.

20+
years of expertise
4
offices Morocco & Africa
48h
response to your request
Why TargetUp University

A recognised training partner

Expert trainers

Practitioner speakers, certified and recognised in their field.

Recognised Certifications

Paths aligned with international standards and organisations.

Anchoring Morocco & Africa

In-person and remote sessions, tailored to the local context.

Dedicated Support

A training advisor supports you from programme selection to certification.

Active pedagogy

Practical cases, situational exercises and personalised support.

Accreditation Network

A recognised ecosystem of certifications and affiliations.

Frequently asked questions

You may be wondering…

Is the training certified?
Yes: a TargetUp University certificate (or the targeted certification exam) validates your achievements at the end of the course.
In-person or remote?
Our sessions are held in person (Morocco) and remotely, for participants from across Francophone Africa.
How do you register?
Fill out the form below: a training advisor will contact you within 48 hours with the details and schedule.

Training Registration

Fill out this registration form: a TargetUp University advisor will contact you within 48 hours (programme and schedule).

Your registrationUniversity — Quality, Audit & ISO CertificationsPECB ISO 13485 Lead Auditor — Medical Devices

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