confinis ag
hauptstrasse 16
3186 düdingen
switzerland

phone: +41 26 494 8 494
fax: +41 26 492 5 071

confinis usa
2511 st. ignatius court
orlando, FL 32835
usa

phone: +1 (386) 299 5218
fax: +1 (407) 296 7139

welcome to confinis

confinis is an international consultancy specializing in providing professional services and advice to companies in medical device, pharmaceutical, biotech and diagnostic industries.

confinis' core competences are in business practices and include

strategic management
innovation management
project portfolio management (device development strategy)
project management with particular expertise in new product development (idea through design and registration to commercialization)
validation according to GAMP 5 (computer system validation, test method validation, cleaning validation etc.)
design and validation of manufacturing lines and whole facilities
product risk management (ISO 14971) and usability engineering (IEC 62366)
software development life cycle (IEC 62304)
21 CFR part 11 compliance (electronic records; electronic signatures)
quality system development (FDA QSR 21 CFR part 820, ISO 13485, MDD 93/42/EEC, canadian medical device regulations)
technical assessments of products and processes
technical due diligences (mergers, acquisitions, license agreements)
registration of medical devices in europe, usa, japan, china and other markets
auditing and gap analyses