Unimed

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Services applied: Upgrade of Good Manufacturing Practices and Quality Management System from ISO 9001:2008 to ISO 13485:2016. Certified December 2018.

LATECBA S.A.

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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

posted in: Clients | 0

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.

posted in: Clients | 0

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.

posted in: Clients | 0

Services applied Strategic analysis. Costs. ANMAT certification as Manufacturer according to disp.2319/02. New Knee Implant Design

Mecanizados Gabriel S.A.

posted in: Clients | 0

Services applied Development of Design History File. Risk Analysis. Implantable medical device testing. Good manufacturing practice system update

VL Implants

posted in: Clients | 0

Services applied Adequacy of Good Manufacturing Practices system according to requirements Disp 3266/13 ANMAT

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