ABOUT THE COMPANY
Signifix is a consulting company with passionate and experienced consultants in the field of medical devices, cell therapies, human tissues, vaccines and other biological medicines. We are proud to have been successfully serving our (inter)national customer base for more than 15 years.
All our consultants have a strong and diverse industrial background combined with in-depth scientific R&D knowledge. We speak your language and understand your products.
Our regulatory and quality expertise helps in addressing your needs and challenges towards product approval and maintaining compliance.
Signifix’ seasoned and highly skilled professionals have proven track records of successful & timely product development and approval processes in both EU and US, combined with effective implementation of certified quality systems.
Signifix is your partner for Quality and Regulatory compliance in the MedTech and Biotech. We help to bring your innovative medical product to the market.
Signifix has seasoned and highly skilled professionals with an established industrial background and proven track record of successful & timely product development and approval processes, combined with effective implementation of certified quality systems.
Signifix is a boutique consulting company and focussed on innovative biomedical, biotechnology & human tissue medical product technologies. The road to approval is not simple such as advanced therapy medicinal products, medical devices, animal tissue devices and combination/borderline medical solutions. Our range of consultancy services covers quality & regulatory strategies, design and implement quality systems, managing regulatory approvals (including 510(k), PMA, IDE, IND, BLA and CE mark). Support quality system certification processes in all phases of product development, auditing (internal/ vendor), training/ coaching and problem solving. We help to bring your innovative medical solution to the market.