Our ISO 13485 training programs are designed to help professionals and organizations understand, implement, and audit Quality Management Systems (QMS) for medical devices. Based on ISO 13485:2016, these courses address regulatory compliance, product safety, and quality requirements for organizations involved in the design, production, installation, and servicing of medical devices. Whether you are new to medical device quality management or seeking to become a certified lead auditor, our courses provide practical and globally recognized training.

1. ISO 13485 Awareness Training

• Duration: 1 day

• Audience: Medical device manufacturers, suppliers, quality staff, and regulatory teams

• Objective: To introduce the core requirements of ISO 13485 and its role in ensuring medical device quality and safety

• Outcome: General awareness — no exam required

2. ISO 13485 Foundation Training

• Duration: 2 days

• Audience: Staff responsible for developing, implementing, or maintaining QMS in the medical device industry

• Objective: To provide a detailed overview of ISO 13485 clauses, documentation needs, and regulatory integration

• Outcome: Participation certificate — no exam required

3. ISO 13485 Internal Auditor Training

• Duration: 2 days

• Audience: Quality managers, internal auditor candidates, and regulatory compliance officers

• Objective: To develop auditing skills for QMS in medical device organizations in line with ISO 19011 and ISO 13485

• Outcome: Certificate of Achievement upon passing final assessment

4. ISO 13485 Lead Auditor Training (Exemplar Global or PECB Approved)

• Duration: 5 days

• Audience: Professionals aiming to conduct or lead third-party QMS audits in the medical device sector

• Objective: To build competence in auditing ISO 13485 systems, managing audit teams, and reporting findings

• Outcome: Internationally recognized Lead Auditor Certificate — Exam is required

5. ISO 13485 Lead Implementer Training (Exemplar Global or PECB Approved)

• Duration: 4–5 days

• Audience: Project managers, consultants, and implementation leaders in the medical device industry

• Objective: To provide the skills to establish, implement, and maintain a QMS aligned with ISO 13485 and regulatory requirements

• Outcome: Internationally recognized Lead Implementer Certificate — Exam is required

We offer flexible training formats to suit your schedule and learning preferences:

• On-Site (Face-to-Face) Training
  Conducted in person at your location for an interactive classroom experience.

• Live Online Training
  Delivered in real time via virtual platforms with instructor interaction, group discussions, and Q&A.

• Self-Paced Online (Recorded) Training
  Pre-recorded sessions you can access anytime, anywhere — ideal for independent learning.

Contact us: info@bbs-cert.de

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