Impurity identification by LC-QTOF (database of more than 1000 substances)
Pedagogical resources
- Screening of training material
- Handover of training material
- Training led by experts in the techniques required
Target audience
Technicians or engineers in charge of research & innovation, process & industrialisation, production & maintenance, quality control, health, safety & environment, purchasing & supplies …
Program
For more information on the program, please contact us
Information updated on 09.10.2024
Practical information
- In-company training
- Questionnaire at the beginning and end of the course (Quizzes)
- Attendance sheet
- Duration: 2 days
- PRM and PSH accessibility
- Adaptable to customer needs
- Price on quotation
- No pre-requisites required for this course
- A certificate of completion will be issued at the end of the course.
Our training courses are accessible to people with disabilities. We will offer you solutions for adaptations (e.g. training aids, pace of training, teaching support, etc.) and adjustments to suit your needs.
Your teams need training on the ISO 10993-18 standard...
What is the ISO 10993-18 standard about?
The ISO 10993-18 standard describes a framework for the identification of a material and the determination and quantification of its chemical compounds. Therefore, ISO 10993-18 allows to ensure the biocompatibility of the medical device under study.
Indeed, the identification of biological hazards as well as the estimation and control of biological risks related to the constituents of materials according to the ISO 10993-18 standard are more than essential steps. Thus, several elements of chemical characterization are studied:
- the determination of chemical substances released by a medical device under its specific clinical use conditions
- the identification of the materials constituting the medical device
- characterization of the constituent materials via the identification and quantification of the chemical constituents (composition of the material)
- chemical substances introduced during the manufacturing of the medical device: release agents, sterilization residues…
FILAB's ISO 10993-18 training...
As an accredited training organization, FILAB offers customized training for the analysis and chemical characterization of materials in medical devices in accordance with the requirements of ISO 10993-18.
At FILAB, we develop and offer our customers tailor-made training courses, in line with your industrial issues or analytical challenges.
To register for the course or to obtain a quote, please contact us directly by email or telephone.
Training will start within 3 months of acceptance of the agreement.
Why use FILAB for any training in analytical chemistry or materials?
FILAB is QUALIOPI certified for its training activities. This certification allows the training we provide to be eligible for funding from OPCOs.
Analytical training is essential for professionals seeking to master analytical and characterization techniques. It encompasses a wide range of techniques for analyzing and characterizing substances, materials, or products in various industrial sectors.
Our analytical training programs are designed to equip participants with the skills needed to excel in their field, combining rigorous theory with practical applications. Discover how our analytical training programs can transform your company’s skillset.
There are several reasons for the growing number of requests for training at FILAB:
Tailor-made technical training: most of the training offered by many training organizations is standard, not tailor-made, and does not address your technical issues
Highly qualified people: our trainers are people from the laboratory, doctors or specialized engineers
Industrial knowledge: FILAB has been providing training to its clients for over 10 years, regardless of the industrial sector
A unique profile with dual expertise in Chemistry and Materials
A structure on a human scale, which allows us better responsiveness and greater flexibility
ISO 10993-18: when training your teams boosts compliance and innovation
- Development of new medical devices
- Anticipation of regulatory audits and inspections
- Optimization of interactions with subcontractors and partner laboratories
- Continuous improvement and product innovation
- Reduction of costs related to analytical and regulatory errors
FAQ
Objectives include: AET calculation, impurity identification by LC-QTOF (base >1000 substances), determination of organic and inorganic residues (ICP, CLI, GC/MS, LC, HS/GCMS) and validation of extraction completeness according to ISO 10993-12.
It is aimed at medical device manufacturers, quality and regulatory affairs managers, as well as R&D engineers wishing to master good chemical characterization practices.
The training strengthens expertise in biological evaluation, secures your regulatory files, reduces risks associated with non-conformities and optimizes the development of innovative medical devices.
The FILAB laboratory offers a tailor-made approach, combining expertise in analytical chemistry and regulatory experience, to effectively support your compliance and innovation projects.
ISO 10993-18 defines the requirements for the chemical characterization of materials used in medical devices. It identifies and quantifies extractable and leachable substances to assess their potential impact on human health. This step is essential for demonstrating the biocompatibility of a device, ensuring its safe clinical use, and meeting international regulatory requirements.
