About SAFE
SAFE Medical Devices Strategy arises as a response to the growing global trend towards more rigorous and specialized legislation in the field of Medical Devices.
Oriented to offer strategic support to SMEs and Start-ups to transform their ideas into Quality Medical Devices; approved within reasonable deadlines and always guaranteeing compliance with the Quality Management System, as well as the safety and efficacy of the product.
Specialized in Medical Devices, and with extensive experience in vertically integrated companies – from injection and assembly to automation, sterilization, packaging and quality control – we offer specialized services in all key areas of Quality:
Regulatory
Affairs
Quality
Assurance
Quality
Control
Clinical
Affairs
Regulatory Excellence
Vision
Guide small medical device companies and startups through the regulatory framework to help them achieve their purpose.
Mission
To support companies by applying customized and strategic solutions at the Quality level, based on more than 30 years of practical experience in production and regulatory compliance.
Values
Honesty, knowledge and commitment to ensure compliance with the highest quality standards on schedule.
David Salvatierra - Founder
More than 30 years of experience in the Medical Devices sector as Quality Director and as member of Boards of Directors.
Degree in Chemical Sciences with a Postgraduate Degree in Business Administration, Postgraduate Degree in Microbiology and PDD at IESE. Lead Auditor ISO 13485 CQI/IRCA.
Experience in Business Management, Quality Systems, Regulatory Affairs, Clinical Area and Quality Control.
Used to manage multidisciplinary teams as well as relationships with customers, Health Authorities and Notified Bodies.
My background includes product approvals in Europe (CE Marking -MDR- of sterile and non-sterile products) and all classifications (Class I to Class III implantable); USA (510K Class II) and Sanitary Registrations in countries such as China, India, Brazil or Canada.
Results-oriented and problem-solving.
