Technical Documentation Training within the Scope of (EU) 2017/745 Medical Device Regulation (MDR)

For all new or existing medical devices placed on the market within the borders of the European Union, regardless of risk class, manufacturers are required to prepare Technical Documentation to show that they meet the General Safety and Performance Requirements of Annex I of the (EU) 2017/745 Medical Device Regulation. This documentation must be prepared in accordance with Annex II and Annex III of the (EU) 2017/745 Medical Device Regulation and updated when necessary. 

Purpose of Training:

The requirements for preparing technical documentation within the scope of the (EU) 2017/745 Medical Device Regulation, details on the issues to be considered during the certification process, and details to be aware of updates when necessary throughout the entire process are designed to ensure that you understand the process of preparing and maintaining technical documentation in accordance with the legislation and adequately.

Content of the Training:

Goals of Technical Documentation

Supporting documents (MEDDEV, GHTF and similar)

Basic overview of MDR requirements regarding technical documentation

Structure of a medical device technical documentation

Grouping of medical devices within the scope of technical documentation

Classification of medical devices

Technical Documentation content according to the Medical Device Regulation

Identification of Device-related Changes (model, variant, version, etc.)

GSPR

Key components of risk management and risk analysis

Documenting the design – product design and development process

Product verification tests

Use of harmonized standards and situations where standards are incorrectly applied

Biological Evaluation Process

availability

Sterilization

Process Validation Processes

Clinical Evaluation

Label and User Manual

Declaration of Conformity

Post-Market Surveillance Documents

Responsible person's duties regarding Technical Documentation

Technical Documentation Evaluation Processes in Audits

Education Activity Questions

Who Should Participate:

• Licensing Experts
• Medical Device R&D Engineers
• Medical Device Manufacturers
• Internal and External Auditors
• Quality Managers
• Development, Production and Marketing Managers
• People who want to improve themselves in technical documentation
• Consultants

Benefits of Education:

Ability to prepare robust technical documentation to demonstrate compliance with MDR

Ability to better understand the legal requirements and Notified Body expectations in order to ensure that the certification process is active and efficient.

Ability to understand situations where technical documentation needs to be updated

Ability to understand the importance of common specifications and standards in preparing technical documentation

Ability to identify nonconformities in advance in the technical documentation evaluation process

Reference Sources:

(EU) 2017/745 Medical Device Regulation

MDCG Guides

Tuition Fee:

Please send an e-mail to info@udem.com.tr to get information about training fees. If there are 3 or more participants from the same company/institution, a 10% discount will be given. A 10% discount will be provided for participants who register early.

Education Record:

To complete the training registration, please fill out the training registration form in the link below and send an e-mail to info@udem.com.tr.

Detailed Information:

For detailed information about the training, you can contact us through the following communication channels.

Tel: +90 312 4430390

Mail: info@udem.com.tr