Our experience in life sciences allows us to contribute throughout the life cycle of a pharmaceutical product or medical device project.
Medical Devices R&D
Development and Electronic Validation, mechanics, automation, usability and human factor.
Industrialisation, Qualification and Validation, New-Build and Refurbishment Works
Qualification of equipment, process and computer system validation, management of engineering projects, refurbishment.
Regulatory Affairs
Drafting and updating of technical files (510(k) and CE marking), version management for ISO 13485, Registration/Submission for the FDA, Europe, China, Change Control, Labelling.
Quality
Systems quality, operational quality, product quality.