IVDR- MDR SOLUTIONS

Technical Documentation: A Comprehensive Guide to Medical Devices

Technical documentation is a comprehensive source of information on the development, design and manufacturing of medical devices. Each medical device manufacturer must prepare the technical documentation of the products it produces, keep it up to date and integrate it with the existing quality management system.

Technical documentation is critical for the safe and effective use of medical devices. This documentation contains detailed information on the operating principles of the device, operating instructions, possible risks, maintenance and repair procedures and other technical information.

The main functions of technical documentation are:

User guidance: To ensure that users use the device correctly and safely.
Compatibility: To document that the device complies with the relevant legal and technical regulations.
Information sharing: To collect technical information about the device in one source and share it with the relevant people.
Quality management: To provide the necessary information for monitoring and improving production processes.

Technical documentation plays an important role throughout the lifecycle of medical devices. While it guides the design and development of the device during the production phase, it ensures that users use the device correctly and safely during the usage phase. It also supports device compliance with legal and technical regulations and continuous improvement of production processes.

Technical Documentation indicates that the medical device to which it is applied complies with the 2017/746 IVDR General Safety and Performance Requirements.

Guiding information on what the technical documentation should include is given in Annex II of the IVDR regulation 2017/746.

Device description and characteristics, including variants and accessories (Regulation (EU) 2017/746 (IVDR), Annex II Part 1)
Information provided by the manufacturer (Regulation (EU) 2017/746 (IVDR), Annex II Part 2)
Design and production information (Regulation (EU) 2017/746 (IVDR), Annex II Part 3)
General Safety and Performance Requirements (Regulation (EU) 2017/746 (IVDR), Annex II Part 4)
Benefit-Risk Analysis and Risk Management (Regulation (EU) 2017/746 (IVDR), Annex II Parts 5 and 6)V
Summary of Safety and Performance (SSP) (class C and D devices only) (Regulation (EU) 2017/746 (IVDR), Article 29)

MDR SOLUTIONS

IDENTIFICATION AND TRACEABILITY

The Medical Device Regulation (MDR) requires medical device manufacturers to use unique device identification (UDI) mechanisms. The main purpose of this regulation is to improve the ability of manufacturers and authorities to track specific devices throughout the supply chain and to facilitate the rapid and effective recall of in vitro diagnostic medical devices found to pose a safety risk.

UDI is a unique code assigned to each medical device and distinguishes it from all other devices. UDIs enable various stakeholders, such as manufacturers, distributors, healthcare organizations, and patients, to identify, track, and manage medical devices. According to the MDR, UDIs must contain the following information:

Device manufacturer's name and trademark

Production date or serial number

Trade name or model number of the device

UDI's assignment number

All information regarding UDI and approved devices will be available through the European Medical Devices Data Bank (EUDAMED). EUDAMED is a database designed to increase transparency and information sharing about medical devices.

EUDAMED

The establishment of a European database on medical devices (EUDAMED) is a key element of the new rules on in vitro diagnostic medical devices (Regulation (EU) 2017/746).

EUDAMED will provide a vivid picture of the life cycle of medical devices introduced into the European Union (EU). EUDAMED aims to increase overall transparency and improve coordination between different Member States in the EU, including better access to information for the public and healthcare professionals.

EUDAMED consists of six modules related to:

Actor and User Registration and Management

UDI Database and Registration of Devices

Certificates and Notified Bodies

Clinical Review and Performance Studies

Vigilance and Post-Market Surveillance

Market Surveillance

UDI
(UNIQUE DEVICE ID)

Benefits of UDI:

It prevents counterfeiting and counterfeit products of medical devices.
Facilitates device recalls and field safety remediation activities.
It enables the monitoring of medical devices in clinical research.
Supports pharmacovigilance and public health surveillance activities.

Under the new rules, before any manufacturer places a device on the market, it will assign a UDI to the device and all upper levels of packaging. The UDI carrier must be placed on the label of the device and on all upper levels of packaging.

Following a call for applications launched at the end of 2018 and Commission Implementing Decision (EU) 2019/939 of 6 June 2019, 4 regulatory bodies have been designated to provide manufacturers with a list of UDIs to assign to medical devices.

Verification & Validation

Verification and validation (V&V) methods are systematic approaches that are widely used and applied in various disciplines. These methods are intended to evaluate whether products and systems meet certain requirements and successfully fulfill their intended use.

Verification:

Validation is the process of checking whether a product or system meets the requirements and specifications defined during the development phase. This process includes reviewing the product or system's design, code, and documentation; It includes performing tests and analyzes and evaluating the results. With verification, it is ensured that the product or system is technically correct and error-free.

Validation:

Validation is the process of evaluating whether a product or system successfully fulfills its intended use and anticipated functions. This process involves testing the product or system by real users and in real usage scenarios and analyzing the results. With validation, it is ensured that the product or system is practically useful and useful.

Importance of V&V Methods:

V&V methods are critical to improving the safety, reliability and quality of products and systems. These methods help detect and fix errors and defects at an early stage. It also ensures that products and systems meet customer requirements and expectations.

As the Medical Devices Institute, we emphasize the importance of verification and validation (V&V) activities to increase the safety and effectiveness of medical devices. V&V is critical not only to comply with legal requirements, but also to protect public health and safety and achieve broader business success.

Therefore, as the Medical Devices Institute, we believe that V&V activities should be comprehensively planned, regularly updated and aligned with general company procedures. Our institute offers a variety of services to help medical device manufacturers improve their knowledge and skills in V&V.

ISO 13485 QMS

The safe and effective production and marketing of medical devices is strictly controlled by national and international regulations. A key requirement of these regulations is that medical device manufacturers establish and maintain a Quality Management System (QMS).

QMS consists of a set of policies, processes and procedures that provide a systematic approach to planning, executing and controlling all essential business functions of an organization. The main purpose of QMS in the medical device industry is to ensure a consistent level of quality at every stage of the production and design processes.

Scope of QMS:

A medical device company's QMS should cover all business processes from production to marketing and all elements of the devices produced. In this context, QMS iswhich includes fields:

Control of production and design processes: Monitoring and controlling all production stages from raw materials to the final product to ensure the production of quality and safe products.
Documentation control: Documenting and keeping up to date all quality-related procedures, instructions and records.
Personnel training: Training and awareness-raising of personnel to ensure effective implementation of the quality system.
Internal audit and improvement: Conducting regular internal audits to evaluate the effectiveness and suitability of the system and ensuring the necessary improvements.
Management responsibility: Establishing a structure that demonstrates top management's commitment to the QMS and its contribution to the continuous improvement of the system.

Compatibility with Target Markets:

Medical device manufacturers must adapt their QMS to comply with the regulations and standards of their target markets. This is important considering that different countries may have different regulations.

The quality system provisions of the European Union are set out in Article 10 of Regulation EC 2017/745 and Annex IX (Regulation EC 2017/746 in the case of in vitro diagnostic devices).

As the Medical Devices Institute, we offer a comprehensive assessment service to help you create and develop a Quality Management System (QMS) that suits your organization's specific needs. Our expert team helps you comply with industry best practices and comply with legal requirements by ensuring that all implementation requirements of the ISO 13485 quality management systems standard for medical devices are addressed in your QMS.

Within the Scope of Our Evaluation Service:

A comprehensive analysis of your organization's current situation and needs
Evaluation of your QMS for compliance with the ISO 13485 standard
Identifying missing or incompatible elements in your QMS
Providing recommendations for the development and implementation of a QMS that suits your needs
Review and improve documentation and procedures related to the QMS
QMS training and awareness activities for your staff

13485 QUALITY MANAGEMENT SYSTEM TRAINING

Educational Goals:

Understand the basic principles and terminology of the ISO 13485 standard
Understanding the importance and benefits of a quality management system in the medical device industry
To systematically analyze the terms and requirements of the ISO 13485 standard
Learning the steps necessary to establish and implement an effective quality management system
Understand the application of critical elements such as risk management, documentation control and internal audit
Improving the efficiency and performance of the system using the continuous improvement cycle

Benefits of Education:

Participants will have the necessary knowledge and skills to establish and manage a quality management system compliant with the ISO 13485 standard.
Compliance with legal and regulatory requirements in the medical device industry will be ensured.
With the effective implementation of the quality management system, product and service quality will increase.
Customer satisfaction and market share will increase.
There will be an increase in efficiency and productivity.
The company's overall risk profile will be reduced.

Target audience of the training:

Quality Managers
Licensing Unit Managers
Internal auditors of medical device manufacturers
Functional team members involved in implementation
Professionals who provide audit services to organizations in the sector

Training duration: 2 days

ANALYSIS

Medical Devices Institute's professionals analyze your current system and make the necessary adjustments. It then makes your system ready for use.

QUALITY MANAGEMENT SYSTEM SETUP

We are proud to offer a modern quality management software platform to meet the complex and specific requirements of the medical device industry: Smart QMS.

Smart QMS is preferred by innovative medical device companies operating in more than 600 cities and 50 countries on 6 continents. Our platform was designed with the unique needs of the medical device industry in mind and offers the following key benefits:

1. Easy Application and Use:

With its user-friendly interface and industry-specific configuration, installation and application are completed effortlessly.
Industry-specific terminology and business processes are included in the platform, eliminating the need for additional adaptation.

2. Improved Compatibility:

It facilitates compliance with medical device regulations and standards (ISO 13485, 21 CFR Part 820, etc.) and ensures sustainability.
Updates and changes regarding regulations are automatically tracked on the platform and notified to the user.

3. Reduced Risk:

It minimizes risks and errors by optimizing quality management processes.
Comprehensive risk management tools provide the ability to identify, assess and control industry-specific risks.

4. Accelerated Time to Market:

It allows new products to be introduced to the market faster and more smoothly.
Automation and data analysis tools optimize product development and manufacturing processes.

5. Increased Productivity:

It optimizes business processes and increases efficiency with automation and data analysis tools.
Comprehensive reporting tools provide detailed and customized reports on quality management processes.

Industry-specific advantages offered by Smart QMS:

Comprehensive Risk Management

It offers advanced tools to identify, assess and control risks specific to the medical device industry.

Product Lifecycle Management

Provides comprehensive quality control throughout product development, production, distribution and after-sales phases.

Compliance Modules

Facilitates compliance with ISO 13485, 21 CFR Part 820 and other medical device regulations.

Data Analysis and Reporting

It provides data-based decision making by providing detailed and customized reports on quality management processes.