Credentials · qualifications archive

Certificates & Professional Qualifications

These are Björn Seiler’s formal qualifications. They cover audit, quality management, regulatory affairs, applied methods, and AI in quality work.

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Documented qualifications

These records support MediMotive’s practical quality work. Each certificate is shown as evidence, not a claim. Click any record to view the full document.

Audit

Process and quality audit

Björn Seiler VDA 6.3 Process Auditor certificate — VDA 6.3 Process Auditor VDA · process audit
Process audit competence for supplier and production environments.

Björn Seiler EOQ Quality Auditor certificate — EOQ Quality Auditor EOQ · audit
European Organization for Quality auditor qualification.

Methods

Björn Seiler TÜV Methods Certificate certificate — TÜV Methods Certificate TÜV · methods
Automotive Core Tools - Methods for quality work.

Björn Seiler ISO 14971 Risk Management certificate — ISO 14971 Risk Management ISO 14971 · risk
Risk management methods for medical devices.

Björn Seiler Design Control certificate — Design Control Medical devices · design
Design control in regulated medical-device development.

Björn Seiler Process Validation for Medical Devices certificate — Process Validation for Medical Devices Medical devices · validation
Process validation qualification for medical-device manufacturing.

Björn Seiler Production and Process Control (PPC) certificate — Production and Process Control (PPC) Medical devices · methods
Production and process control in medical-device contexts.

Quality Management

Björn Seiler Medical Device Advisor (Medidee) certificate — Medical Device Advisor (Medidee) Medical devices · advisory
Medical-device advisory qualification.

Björn Seiler ISO 14001 Environmental Management certificate — ISO 14001 Environmental Management ISO · environmental
Environmental management systems.

Björn Seiler Medical Device Quality Management certificate — Medical Device Quality Management ISO 13485 · medical devices
Quality management in medical-device environments.

Björn Seiler Quality Management Representative (QMR) certificate — Quality Management Representative (QMR) DGQ · QMS
Quality management representative qualification.

Regulatory Affairs

Björn Seiler VDA Product Safety (PSB) certificate — VDA Product Safety (PSB) VDA · product safety
Product safety representative foundation in the VDA context.

Björn Seiler EU-MDR UDI certificate — EU-MDR UDI EU-MDR · regulatory
Unique Device Identification under EU-MDR.

Björn Seiler EU-MDR Technical Documentation certificate — EU-MDR Technical Documentation EU-MDR · regulatory
Technical documentation requirements under EU-MDR.

Björn Seiler EU-MDR PRRC (Article 15) certificate — EU-MDR PRRC (Article 15) EU-MDR · regulatory
Person responsible for regulatory compliance under Article 15.

Björn Seiler Medical Device Regulatory Affairs Manager certificate — Medical Device Regulatory Affairs Manager EU-MDR · risk
RA responsibility in international medical-device markets.

Björn Seiler Post-Market Surveillance certificate — Post-Market Surveillance Medical devices · PMS
Post-market surveillance for medical devices.

AI and other

Björn Seiler LSI Chinese — Level 1 certificate — LSI Chinese — Level 1 Language · Chinese
Language qualification supporting supplier work in Chinese contexts.

Björn Seiler DGQ — ChatGPT in Audits certificate — DGQ — ChatGPT in Audits DGQ · continuing education
Applied use of AI tools in audit contexts.

Björn Seiler DGQ — AI Tools in Audits certificate — DGQ — AI Tools in Audits DGQ · continuing education
Claude, Perplexity, Gemini and related tools in daily QM practice.