LabAnalysis has acquired significant experience and technical expertise in the field of chemical, physical and microbiological analysis. Today, the implementation of services dedicated to Medical Device manufacturers, has allowed to expand the scope of action, implementing activities such as the design and development of chemical-physical and microbiological characterisation studies and subsequent biological evaluation of medical devices, validation of critical processes and production sites.
In addition, a consultancy service is available to support manufacturers in the CE marking process of Medical Devices, for each risk class (I, IIa, IIb and III), according to the Medical Devices Regulation 2017/745.
Activities are performed in accordance with industry standards and guidelines, such as ISO, UNI and ASTM standards, FDA guidelines and Pharmacopoeia (EP, USP).
Studies can be conducted by developing and validating in-house methods.
ISO 17025 accredited tests in the field of Medical Devices, available at the ACCREDIA website, include:
In addition to the accredited tests, the LabAnalysis facility in Casanova Lonati (PV), has several analytical areas available for performing chemical-physical and microbiological tests, both on finished products and on raw materials that make up the medical device. In addition, there are climatic chambers where stability studies can be conducted in accordance with ICH guidelines (Q1A).
Among the different tests that can be carried out, including method validation, are:
Additional services are provided, including
Performing biological evaluation of medical devices according to ISO 10993 series:
Biocompatibility assessments are also performed according to specific standards for different types of medical devices, e.g. on intraocular lenses (ISO 11979-5: Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility), on respirable gas delivery systems (ISO 18562: Evaluation of the biocompatibility of respirable gas pathways in healthcare applications), and on thermal disinfectors (ISO 15883-5: Performance requirements and criteria for test methods to demonstrate cleaning effectiveness).
Designing and developing studies for the validation of critical processes:
Conducting performance studies on specific types of medical devices, such as:
LabAnalysis also deals with the validation and periodic re-qualification of controlled contamination environments, clean rooms and fume hoods, according to ISO 14644, EN 17141 and Annex 1 of the EU GMP guideline, and offers the possibility to perform analyses such as:
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