Education

Our Training Services

A competent workforce is one of the most critical components of a quality management system. Through our training programs, we enhance your personnel’s knowledge level and ensure they are fully prepared for audits. All our trainings are delivered by expert lead auditors in compliance with current regulations and standards.

Training Programs

ISO 13485:2016 – Medical Devices – Quality Management Systems Basic Training (3 Days)
Target Audience: Quality managers, internal auditors, process owners
Content Summary: Detailed interpretation of all clauses of the standard, documentation structure, process approach, audit techniques, and case studies

ISO 13485:2016 – Medical Devices – Quality Management Systems Internal Auditor Training (2 Days)
Target Audience: Quality personnel, internal auditor candidates
Content Summary: Audit planning, preparation of audit questions, evidence collection, nonconformity reporting, corrective action processes, and role-play exercises

ISO 14971:2019 – Medical Devices – Application of Risk Management Training (1 Day)
Target Audience: R&D, production, quality, and regulatory affairs personnel
Content Summary: Risk management planning, hazard identification, risk analysis matrices, risk control measures, benefit-risk evaluation, and residual risk reporting

EU MDR 2017/745 – Technical Documentation and Clinical Evaluation Training (1 Day)
Target Audience: Technical staff, documentation specialists
Content Summary: Annex II & III requirements, technical file structure, preparation of Clinical Evaluation Reports (CER), literature review methods, and use of PMS data

EU 2017/746 (IVDR) In Vitro Diagnostic Medical Devices Regulation Training (2 Days)
Target Audience: Technical staff, documentation specialists
Content Summary:

• General overview of EU 2017/746 IVDR
• Transition process and key differences between IVDD and IVDR
• Detailed review of IVDR articles
• Unique Device Identification (UDI) and the European EUDAMED system
• Technical documentation preparation process in accordance with Annex II

ISO 13485:2016 and Medical Regulatory Awareness Training (½ Day – 4 Hours)
Target Audience: All employees (production, warehouse, sales, administrative staff)
Content Summary: Basic quality management system concepts, overview of ISO 13485 requirements, responsibilities under MDR, and increasing quality awareness

Good Manufacturing Practices (GMP) Training (1 Day)
Target Audience: R&D, production, quality personnel
Content Summary:

• General GMP training based on the latest guidelines of the Turkish Ministry of Health (TİTCK) for advanced therapy medicinal products
• History of GMP and national/international regulations
• What is GMP (Good Manufacturing Practices)?
• Personnel, facilities, and equipment
• Production and quality control
• Complaints and product recalls
• Internal audits

Key Features of Our Trainings

• Certificate of Participation:
  At the end of each training, participants receive a KASCERT-approved, accredited certificate
• Group Trainings:
  Customized training sessions can be organized for groups of at least 4 participants within your organization
• Online Training Option:
  Interactive live training sessions via online platforms
• Customized Content:
  Training programs can be tailored according to your company’s sector and product group