Medical 22/04/2024

Validation of machinery for the assembly and testing of medical devices

Medtech Solutions

Compliance and reliability: Sinteco's experience in supporting validation for the Medtech Sector

In the complex realm of the medical industry, validation plays a pivotal role in ensuring the safety and effectiveness of devices and products intended for patient care.

In this context, Sinteco is committed to providing cutting-edge automated solutions for assembly and testing, adhering to rigorous standards of quality and regulatory compliance.

Impianto di automazione robotizzato per assemblaggio di dispositivi medicali

Robotic Lines and Complex Automation Systems

Sinteco specializes in designing and building robotic lines and complex automation systems for assembling and testing medical devices. Tailoring our approach to meet each client's needs, we adhere closely to Good Manufacturing Practice (GMP) guidelines and Guidelines for Process Automation (GAMP) to ensure utmost quality and regulatory compliance.

These guidelines provide a strong framework for designing, building and installing our systems, ensuring that our products meet high standards of quality, reliability and safety.

La validazione in fase di progettazione

Design Validation

Validation during the design phase is essential to ensure that medical devices are manufactured using automated processes that meet safety and performance standards. This process includes developing and executing documents like the Functional Design Specification (FDS) and the User Requirement Specification (URS), which outline the system's functions and user needs, respectively.

A proper validation procedure in this phase requires careful planning and detailed analysis of potential risks. During the machine implementation phase, Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) tests are conducted to ensure that the system has been installed correctly, operates as expected and maintains reliable performance over time.

Software Validation

Within the medical and pharmaceutical industries, the realm of software is increasingly vital as many devices and processes are managed by computer systems. Software validation is thus imperative to ensure the integrity, safety and reliability of computerized systems used in production and quality control processes.

The software validation procedure includes various activities, such as the creation and execution of system and acceptance tests, as well as compliance verification with CFR 21 regulations (Code of Federal Regulations - Title 21). Developing a well-structured Requirements Traceability Matrix (RTM) is crucial for identifying and addressing any defects or issues within the software.

Supporto alla validazione medicale per assemblaggio di componenti medtech

Customer Validation Support

In addition to strictly adhering to internal guidelines during the design and construction of its assembly and testing systems for medical devices, Sinteco provides its customers with validation support. This includes supplying detailed documentation, supporting the production of test protocols and assisting during system validation phases.

Commitment to Excellence

Understanding the critical importance of validation in the pharmaceutical and medical industries, Sinteco is dedicated to ensuring that our automation and services consistently meet the highest standards of quality and safety. With our commitment to excellence and regulatory compliance, Sinteco is prepared to tackle the challenges of the future and be a reliable partner for medical and pharmaceutical multinationals worldwide.

For more information on Sinteco's approach to validation in the Medtech industry, please do not hesitate to contact us.