Introduction
Training Activities
At DI Quality Certification Services Pvt. Ltd. (DI QCS), we offer professional training programs tailored to meet the evolving needs of the medical device industry. Our training courses are developed by subject matter experts and are designed to:
Enhance personal competencies- Support sustainable business development
- Equip participants with regulatory and quality management system knowledge
These trainings include lectures, hands-on workshops, and exercises conducted by experienced tutors and ISO lead auditors.
Certification Process
Training Courses Offered
Course Details
Provides an overview of ISO 9001 requirements. Ideal for anyone involved in developing, implementing, or managing a QMS.
Key Outcomes:
- Understand ISO 9001 clauses
- Improve customer relationships and operations
- Combine lecture and workshop-based learning
Designed to develop skills needed to perform internal audits of a QMS based on ISO 9001 standards.
Key Outcomes:
- Plan and conduct ISO 9001 internal audits
- Collect objective evidence through interviews and observation
- Practice reporting and corrective action techniques
Provides the knowledge and skills required to lead and perform third-party audits of QMS as per ISO 9001.
Key Outcomes:
- Understand ISO 9001 and audit principles in depth
- Conduct full-scale audits and prepare compliance reports
- Apply audit techniques aligned with international certification processes
Introduces the requirements of ISO 13485 for medical device quality systems. Suitable for professionals new to MD-QMS.
Key Outcomes:
- Understand ISO 13485 structure and clauses
- Recognize its role in medical device regulatory compliance
- Participate in lecture and workshop-style sessions
Develops skills to perform internal audits on medical device QMS in line with ISO 13485:2016.
Key Outcomes:
- Plan, conduct and document internal audits
- Collect and evaluate evidence from MD-QMS processes
- Write audit reports and recommend corrective actions
Introduces the structure and content of U.S. FDA 21 CFR regulatory requirements.
Key Outcomes:
- Understand FDA's approach to medical device regulation
- Learn how CFR impacts quality and compliance in devices
Introduces biological risk evaluation for medical devices as per EN 10993-1.
Key Outcomes:
- Understand testing requirements within a risk-based framework
- Learn biological evaluation strategies for device safety
Explores ISO 14971’s approach to applying risk management throughout a device's lifecycle.
Key Outcomes:
- Understand principles of risk management in medical devices
- Learn how to implement risk processes per ISO 14971
Comprehensive course to lead third-party audits of MD-QMS in conformance with ISO 13485:2016.
Key Outcomes:
- Conduct complete audits and assess compliance
- Align audit practice with MDR/FDA expectations
- Develop professional-level audit reports
Covers the basic structure and intent of the European Medical Device Regulation (MDR).
Key Outcomes:
- Understand MDR definitions, classification and obligations
- Identify changes from MDD to MDR
- Build regulatory awareness
Focuses on applying MDR requirements, including technical documentation and ISO 13485 integration.
Key Outcomes:
- Understand MDR compliance framework
- Prepare technical files and regulatory submissions
- Apply ISO 13485 terminology in MDR context
Introduces MDR as it applies to In Vitro Diagnostic (IVD) devices.
Key Outcomes:
- Understand IVD classification and MDR applicability
- Learn essential terms and obligations for manufacturers
Provides tools to implement IVD MDR, covering ISO 13485, documentation and conformity.
Key Outcomes:
- Apply certification and documentation strategies
- Align IVD systems with MDR and ISO 13485 standards
Covers EO sterilization process validation and control in accordance with EN ISO 11135.
Key Outcomes:
- Learn EO process requirements
- Understand regulatory needs for EO sterilized devices
Focuses on gamma radiation sterilization and its regulatory requirements.
Key Outcomes:
- Understand ISO 11137 sterilization principles
- Ensure compliance in radiation-processed medical devices
Comprehensive course to lead third-party audits of MD-QMS in conformance with ISO 13485:2016.
Key Outcomes:
- Conduct complete audits and assess compliance
- Align audit practice with MDR/FDA expectations
- Develop professional-level audit reports
Provides an overview of ISO 9001 requirements. Ideal for anyone involved in developing, implementing, or managing a QMS.
Key Outcomes:
- Understand ISO 9001 clauses
- Improve customer relationships and operations
- Combine lecture and workshop-based learning
Designed to develop skills needed to perform internal audits of a QMS based on ISO 9001 standards.
Key Outcomes:
- Plan and conduct ISO 9001 internal audits
- Collect objective evidence through interviews and observation
- Practice reporting and corrective action techniques
Provides the knowledge and skills required to lead and perform third-party audits of QMS as per ISO 9001.
Key Outcomes:
- Understand ISO 9001 and audit principles in depth
- Conduct full-scale audits and prepare compliance reports
- Apply audit techniques aligned with international certification processes
Introduces the requirements of ISO 13485 for medical device quality systems. Suitable for professionals new to MD-QMS.
Key Outcomes:
- Understand ISO 13485 structure and clauses
- Recognize its role in medical device regulatory compliance
- Participate in lecture and workshop-style sessions
Develops skills to perform internal audits on medical device QMS in line with ISO 13485:2016.
Key Outcomes:
- Plan, conduct and document internal audits
- Collect and evaluate evidence from MD-QMS processes
- Write audit reports and recommend corrective actions
Comprehensive course to lead third-party audits of MD-QMS in conformance with ISO 13485:2016.
Key Outcomes:
- Conduct complete audits and assess compliance
- Align audit practice with MDR/FDA expectations
- Develop professional-level audit reports
Covers the basic structure and intent of the European Medical Device Regulation (MDR).
Key Outcomes:
- Understand MDR definitions, classification and obligations
- Identify changes from MDD to MDR
- Build regulatory awareness
Focuses on applying MDR requirements, including technical documentation and ISO 13485 integration.
Key Outcomes:
- Understand MDR compliance framework
- Prepare technical files and regulatory submissions
- Apply ISO 13485 terminology in MDR context
Introduces MDR as it applies to In Vitro Diagnostic (IVD) devices.
Key Outcomes:
- Understand IVD classification and MDR applicability
- Learn essential terms and obligations for manufacturers
Provides tools to implement IVD MDR, covering ISO 13485, documentation and conformity.
Key Outcomes:
- Apply certification and documentation strategies
- Align IVD systems with MDR and ISO 13485 standards
Introduces the structure and content of U.S. FDA 21 CFR regulatory requirements.
Key Outcomes:
- Understand FDA's approach to medical device regulation
- Learn how CFR impacts quality and compliance in devices
Explores ISO 14971’s approach to applying risk management throughout a device's lifecycle.
Key Outcomes:
- Understand principles of risk management in medical devices
- Learn how to implement risk processes per ISO 14971
Covers EO sterilization process validation and control in accordance with EN ISO 11135.
Key Outcomes:
- Learn EO process requirements
- Understand regulatory needs for EO sterilized devices
Focuses on gamma radiation sterilization and its regulatory requirements.
Key Outcomes:
- Understand ISO 11137 sterilization principles
- Ensure compliance in radiation-processed medical devices
Introduces biological risk evaluation for medical devices as per EN 10993-1.
Key Outcomes:
- Understand testing requirements within a risk-based framework
- Learn biological evaluation strategies for device safety