BERICAH LABORATORY: PHYSICAL AND MECHANICAL TESTING FOR MEDICAL DEVICES AND PPE COMPLIANT WITH EUROPEAN REGULATIONS
The Bericah in-house laboratory for physical and mechanical testing is the company facility dedicated to technical controls on Medical Devices (MD) and Personal Protective Equipment (PPE).
Through targeted testing activities, the laboratory verifies product performance and helps ensure compliance with the declared requirements.
The laboratory serves as an operational safeguard to protect the reliability and safety of products distributed in the healthcare and industrial sectors, reinforcing the company’s commitment to high quality standards and rigorous controls.
WHAT IS THE PHYSICAL AND MECHANICAL TESTING LABORATORY?
The laboratory performs tests on the finished product to assess key physical and mechanical properties relevant to its intended use, including:
- Tensile strength
- Elasticity and flexibility
- Structural integrity
- Stability over time
- Performance under simulated conditions of use
These tests are part of internal control activities supporting the quality management system and enable verification of product consistency with the technical specifications declared by the supplier and with the applicable requirements for the medical device and PPE sectors.
LABORATORY INSTRUMENTATION: DATA-DRIVEN QUALITY CONTROL
The Bericah laboratory is equipped with professional instruments integrated into the company’s quality management system:
SINGLE-COLUMN TENSILE TESTER
Used for universal tensile and compression tests, it enables precise measurement of the applied force and verification of material strength. It is essential for demonstrating compliance with the technical requirements set out in the applicable reference standards.
SAMPLE CUTTING PRESS
Designed for the controlled cutting of lightweight and medium-thickness materials, it ensures standardized specimen preparation, a key requirement for repeatable and validatable testing.
ACCELERATED AGING INCUBATOR
It enables the simulation of controlled environmental conditions to assess product stability and durability over time, supporting predictive performance analysis.
REGULATORY COMPLIANCE AND MEDICAL DEVICE REGULATION (MDR)
With the introduction of Regulation (EU) 2017/745 on Medical Devices (MDR), controls throughout the supply chain have become increasingly stringent.
The Bericah laboratory:
- Strengthens verification activities on raw materials and finished products
- Supports the technical documentation required by the Regulation
- Contributes to risk management in accordance with European standards
- Anticipates regulatory updates in the medical sector
The objective is to ensure that every product placed on the market is safe, traceable, and compliant with the applicable regulatory requirements.
BENEFITS FOR CUSTOMERS, PUBLIC TENDERS, AND PARTNERS
The laboratory is not merely a testing facility, but a data-driven quality control system based on measurable parameters, enabling:
- Enhanced day-to-day product monitoring
- The provision of objective technical evidence in public tenders
- Increased credibility with healthcare institutions and procurement professionals
- Reduced risk of non-conformities
This integrated approach strengthens Bericah’s positioning as a company focused on certified quality, technical reliability, and international regulatory compliance.
