Medical Devices
Laboratory assessment of medical devices to ensure safety, quality, and compliance with applicable regulatory requirements. Services include microbiological, sterility, physico-chemical, and performance testing.
Intro
Laboratory evaluation ensures the safety, performance, and regulatory compliance of medical devices. Microbiological, physico-chemical, and performance testing supports manufacturers and healthcare providers in achieving quality and safety certification. Sample types include surgical masks, gauzes, prostheses, medical instruments, and catheters.
Why perform this service
Types of analyses performed
They consist of carrying out laboratory tests that make it possible to assess the physical properties of materials and products, such as strength, permeability, or behavior under different conditions. These tests are essential to verify performance, quality, and compliance with regulatory and standard requirements.
Laboratory tests that detect, identify and quantify microorganisms (bacteria, fungi, yeasts, parasites and others) to evaluate the safety and quality of products and environments.
Laboratory tests aimed at characterizing the composition, structure and physical and chemical properties of a sample, by measuring specific parameters and evaluating the presence of contaminants allowing to verify its quality, safety and legal compliance.
Delivery process
1
Sampling plan
Definition of strategic collection points and frequency of analyses according to the needs of each client.
2
Parametric values
Legal limits established for each parameter, based on public health and environmental quality criteria.
3
Periodic reports
Obligation to communicate the results to the competent authorities and to the public, where necessary.
Applicable legislation
Biogerm is accredited by IPAC according to the NP EN ISO/IEC 17025 standard for various water tests.
Related industry sectors
Health
Related services
Waters
Human consumption
Waters
Legionella in water networks
Environment
Occupational air
Environment