At SESBO Consulting, we develop, adapt medical equipment for multinational medical device companies, and excellently assist in obtaining certifications from ANVISA, FDA, and CE Marking agencies.
We render (ISO 9001, ISO 13485, ISO 14971, IEC 60601-1-8, IEC 62366, and IEC 62304) regulatory implementation guidance, and lead top organizational teams in design control, quality management system development, risk analysis, quality compliance, supplier management, and remediation projects.
As pragmatic problem solvers, we not only go extra mile to enthuse our global clients with seamless dialogue establishment between certification bodies, testing laboratories and regulatory agencies; but also make the world a better place through our expert solutions to resource-challenged companies.
We are dynamic, multicultural and demonstrate first-rate client relationship management skills. With SESBO Consulting, you have a partnership with “handshake quality!”
Our Specialties:
Medical Device Design and Development, IEC 60601-1-8, IEC 62366, IEC 62304, ISO 13485, ISO 14971, FDA Certification, ANVISA Certification, EU CE marking Certification, Regulatory Audits & Compliance, Quality Assurance, Qualification/Validation
Kindly contact us now for an evergreen experience!!!
Company’s Keywords:
fda, medical devices, risk management, safety performance evaluation, ce, remediation services, medical device development, regulatory consultancy, anvisa, assuntos regulatorios, projetos e desenvolviemnto de equipamento medico, regulatory affairs, usability engineering, project management, design control
<1
<
<2020
Your request has been submitted successfully.
Own or work here?