- Fixed price commitments
- Altran Education Services
Country Focus: Medical devices
Altran Italia provides to medical device manufacturers engineering services that cover the entire lifecycle of medical products and related processes, within Research and Development projects. Among the main support activities: design, development, verification, validation of the product and monitoring after sales. For every step of product and process lifecycle, Altran Italia can also offer its expertise in key areas such as quality system, process and product safety.
Support in every step of the development cycle of medical device software, in compliance to IEC62304 standard, in particular:
- Software design and implementation
- Functional testing
- Anomalies resolution
- Static code analysis
- Unit testing
- Integration and non-regression testing
- Code review
- Improvement of software development processes and quality of the product
- Requirements management
Application of Risk Management techniques to the whole product development, according to standard EN ISO 14971: planning of activities through the Risk Management Plan, application of risk analysis methods to product and process, preparation of the Risk Management File and management of Post Production Analysis.
Technical and methodological tools used: Hazard Analysis, Product and Process FMEA, Hazop
Biocompatibility of materials and scientific support according to the regulatory framework IS0 10993 and the regulatory text of the Pharmacopoeia
Evaluation of biocompatibility of the finished medical devices for the CE mark. Chemical, physical, mechanical and biological evaluation of materials for the fitness for purpose. Toxicity, substances released, biocompatibility.
Validation of analytical methods
Development of Good Laboratories Practices (GLP) for internal laboratories according to regulatory requirements. Improvement of skills and reliability of the data as required by ISO 17025. Validation of analytical methods, chemical and microbiological, preparation of internal audits, management and calibration of equipment, materials management (chemical or biological origin), development of test plans for activities of biochemical laboratories.
Design and testing of medical devices
Support for definition and verification of product requirements: intended as final product, documentation support, hardware/software components.
Expertise in methods well established in the medical field that include:
- requirement analysis for one or more architecture levels (design input review)
- testing for requirements coverage (functional verification of design output)
- standard compliance assessment by inspection and/or testing in accordance to applicable regulatory framework (EN/IEC60601 general safety, collateral standards, part 2 standards).
Support for CE marking, FDA clearance, Health Canada submissions.
Analysis of product safety in accordance with the applicable standards.
Assessment including the final reports to support certification and 510k file:
- compliance testing of products according to EN/IEC60601 series requirements
- analysis of the product and support for compliance to EN/IEC60601 3rd edition regulatory framework