Leading medical device testing service providers

Medical device manufacturers must demonstrate control over materials, substances and particulate contamination throughout product development and its entire lifecycle. The choice of a medical device testing service provider should therefore be based on the suitability of the protocol, the matrix under study, applicable regulatory requirements and project deadlines.

Medical device testing may involve the physicochemical characterisation of materials, the detection of metallic elements, the identification of organic compounds, particle analysis or residue testing. Filab laboratory supports manufacturers in defining a consistent testing strategy, from material qualification through to the investigation of a non-conformity.

Filab laboratory performs elemental and molecular analysis to characterise the polymers, metals, coatings, adhesives and assemblies that make up a medical device. These investigations can be used to compare materials, identify an unknown substance or detect targeted compounds.

As part of a chemical assessment, an analysis according to ISO 10993-13 can contribute to the characterisation of degradation products generated by polymers.

Working with a single point of contact facilitates consistency between sampling, test specimen preparation, technique selection and result interpretation. This approach is particularly relevant when an investigation requires several analytical methods or when multiple components of the same device need to be compared.

Testing can begin as early as raw material selection, during prototype development, supplier qualification, a formulation change or process validation. It provides objective evidence for comparing technical solutions and establishing control specifications.

Filab laboratory uses complementary analytical techniques to characterise components, raw materials, finished products and extractables from medical devices. Tests are defined according to the manufacturer’s objective: batch comparison, contamination identification, substance detection, cleanliness control or support for a technical file.

To explore your needs in greater depth, see our medical device analysis and ICP analysis of medical devices services.

A particle, abnormal discolouration or deposit can compromise a product’s perceived quality and expected performance. Filab laboratory can conduct targeted investigations to identify the nature of a contaminant, characterise its morphology and guide the search for its source.

Manufacturers of syringes, bags, vials and administration systems can also rely on our expertise in injectable device analysis.

At Filab laboratory, results are presented in a report specifying the scope of the study, the methods used and the analytical observations. The data generated can support quality, regulatory, R&D and production teams in their decision-making.

After market launch, analysis may be required in the event of a complaint, visual defect, particle presence, corrosion, breakage or variation between batches. Filab laboratory then adapts the investigation to the available information and the issue observed.

To initiate your project, send the Filab laboratory a description of the device, the materials involved, the analytical question, the context of use, and the number of samples available. The teams can then propose a suitable testing scope, specify shipping requirements, and schedule the analysis.

Contact the Filab laboratory to define your testing strategy, characterize your materials, identify contamination, and secure your technical decisions.