Engineering
Pacemaker quality
Management of non-conformities and control of pacemaker and defibrillator changes, together with the application of CAPA.
Life sciences
Our Life Sciences Services
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.
SUPPLY CHAIN AND PRODUCTION PROJECT MANAGEMENT
Packaging, serialisation, continuous improvement, Lean production, maintenance, logistics, flow management, compass.
Our Business Areas
Pharmacy
Biotechnology
Medical devices
Our projects
Engineering
Validation of cleaning processes
Drafting of the test protocols and execution of tests for the validation of the equipment cleaning process.
Engineering
Industrial transfer
Coordination and planning of the transfer of a packaging line in an area with activity.