Unimed
Services applied: Upgrade of Good Manufacturing Practices and Quality Management System from ISO 9001:2008 to ISO 13485:2016. Certified December 2018.
Interieur Forma
Services applied: Upgrade of the Quality Mangement System fron ISO 9001:2008 to ISO 9001:2015. Certified November 2018
REGDESK – Philadelphia, USA
Applicability of electronic Instructions for Use (eIFUs) in the Argentine regulatory system. Study of mandatory requirements requested by the Argentine Regulatory Authority (ANMAT).
LATECBA S.A.
Services applied: Risk analysis and usability according to ISO 14971, Risk Analysis and IEC 62304 Software Lifecycle, UNE-EN_62366 Usability, revision and correction of the technical file, technology transfer and clinical evaluation, review Compliance with the international regulatory framework.
Oxigenoterapia Norte
Services applied: Risk analysis and usability according to ISO 14971, Risk Analysis and IEC 62304 Software Lifecycle, UNE-EN_62366 Usability, revision and correction of the technical file, technology transfer and clinical evaluation, review Compliance with the international regulatory framework.
Laboratorios Britania S.A.
Services applied: Risk analysis and usability according to ISO 14971, Risk Analysis and IEC 62304 Software Lifecycle, UNE-EN_62366 Usability, revision and correction of the technical file, technology transfer and clinical evaluation, review Compliance with the international regulatory framework
CorCast S.A.
Services applied Strategic analysis. Costs. ANMAT certification as Manufacturer according to disp.2319/02. New Knee Implant Design
Mecanizados Gabriel S.A.
Services applied Development of Design History File. Risk Analysis. Implantable medical device testing. Good manufacturing practice system update
VL Implants
Services applied Adequacy of Good Manufacturing Practices system according to requirements Disp 3266/13 ANMAT
Insumos Quirúrgicos S.R.L.
Services applied Development of Design History File for different lines of products