ISO 13485
FDA 510(K), PMA, De Novo
ISO/IEC 13485:2016 is an International Standard that specifies requirements for a Quality Management System (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
ISO 13485 Consultation
Medical Device QMS
ISO Certification
ISO is the International Organization for Standardization, an international standard-setting body that facilitates common standards across nations.
Establish Global QMS
Companies need to establish a Quality Management System (QMS) on a global scale.
510(K) Clearance, PMA/DeNovo Approvals
Help with the FDA process