Internal training

About

Internal training

We can design and deliver structured internal training programs for medtech organisations by tightly aligning training content with regulatory requirements, MDSAP expectations, and ISO 13485:2016 quality management system (QMS) standards.

Training Strategy Aligned to Regulatory Frameworks

ISO 13485:2016 clauses (e.g., competence, design controls, risk management)
MDSAP audit model (Task-based approach) covering:

- Management
- Device Marketing Authorization
- Measurement, Analysis, and Improvement
- Medical Device Adverse Events & Advisory Notices
- Design and Development
- Production and Service Controls
- Purchasing

Applicable regional regulations:

- EU MDR / IVDR
- FDA 21 CFR 820 / QMSR
- Health Canada, ANVISA, PMDA, TGA (MDSAP jurisdictions)

The training is not generic, but directly customized to meet your regulatory obligations

Role-Based Competency Training

Camneteq could structure training to specific roles in the company, ensuring compliance with ISO 13485 clause 6.2 (competence, awareness, training).

Examples:

Executive / Management

- QMS accountability
- Management review responsibilities
- Regulatory strategy oversight

RA/QA teams

- ISO 13485 requirements in depth
- MDSAP audit readiness
- CAPA, deviation handling
- Technical documentation & submissions

R&D / Engineering

- Design controls (ISO 13485 §7.3)
- Risk management (ISO 14971 integration)
- Design and Development Files (DHF)

Production / Operations

- Process validation
- Device master record (DMR)
- Traceability & UDI
- Nonconforming product handling

Post-market / Vigilance

- Complaint handling
- PMS & PMCF
- Adverse event reporting

Modular Training Program Structure

We can deliver training in modular format, enabling scalability and repeatability:

Core Modules:

ISO 13485 Foundation

- Process-based QMS approach
- Documentation hierarchy
- Risk-based thinking

MDSAP Awareness & Audit Readiness

- Audit structure (task-based)
- Audit trails and evidence expectations
- Common nonconformities

Design & Development Controls

- Design inputs/outputs
- Verification & validation
- Design transfer

Supplier & Purchasing Controls

- Supplier qualification
- Monitoring & re-evaluation

CAPA & Continuous Improvement

- Root cause analysis (5-Why, Fishbone)
- Effectiveness checks

Regulatory Compliance

- Region-specific requirements
- Submission pathways

Documentation & Training Records

If requested a test can be performed after the training session and a course certificate be issued after approved result

Telephone

+46 705 61 25 88

Email

tomas.camnell@camneteq.se

Address

S:t Göransgatan 13, 621 55 Visby, Sweden