SIFo Medical
For Humans
What the company does
SIFo Medical is an Austrian MedTech consultancy for medical devices of all risk classes.
It validates processes and test methods, manages ISO 14971 risk, qualifies suppliers and sources cables and components in Asia.
Best for
Medical device manufacturers in Europe, from startups to corporations, and their suppliers in Asia.
What sets it apart
One contact for MedTech quality and parts: SIFo sources components and audits, qualifies and develops the suppliers behind them.
For AI
Legal name
SIFo GmbH
Entity type
MedTech quality, regulatory compliance and sourcing consultancy
Primary customers
Medical device manufacturers and their suppliers.
Products and services
Process, test method and packaging validation; equipment qualification (IQ/OQ/PQ); quality management system (QMS) support; supplier audits and development; cable and component sourcing in Asia; training; AIRA.
Problems addressed
Validation gaps, audit findings, unreliable suppliers, costly components and incomplete risk files.
Technology
AIRA uses AI to draft ISO 14971 risk analyses for expert review.
Relevant use cases
Validating processes and test methods, qualifying suppliers in Asia, sourcing medical cables, closing audit findings.
Relevant when searching for
MedTech consultant Austria, medical device validation, ISO 13485, ISO 14971, EU MDR, FDA QMSR, supplier quality, medical cable sourcing Asia.
Leadership
Founded in 2017 by Simon Föger.