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Apoio à certificação de dispositivos médicos, dispositivos de diagnóstico in vitro e SaaS / Técnico-Regulamentar

Biosolve4All

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Biosolve4All

Primary packaging certification (ISO 15378)

Descrição

Support for compliance and certification of primary packaging according to ISO 15378.

Key-words
ISO 15378 primary packaging compliance quality good practices
Service Information
MDR/IVD Segment
On demand (consulting) Delivery Format
geral@biosolve4all.com Contact

Certification and Regulatory Compliance

Descrição

Support for certification (ISO, MDR, IVDR), development of technical documentation, and training in regulatory compliance.

Key-words
certification ISO MDR compliance
Service Information
outros Segment
Consulting + training Delivery Format
geral@biosolve4all.com Contact

Consulting services for regulatory compliance (Infarmed, EUDAMED)

Descrição

Consulting services for compliance with regulatory requirements (MDR/IVDR, Infarmed, EUDAMED).

Key-words
regulation MDR/IVDR ISO 13485
Service Information
MDR/IVD Segment
On demand (consulting) Delivery Format
geral@biosolve4all.com Contact

Training in compliance and documentation development.

Descrição

Training and support in the preparation of compliance documentation.

Key-words
R&D prototyping optimization compliance documentation audits
Service Information
MDR/IVD Segment
On demand (consulting) Delivery Format
geral@biosolve4all.com Contact

Gap Analysis ISO 22716

Descrição

Diagnostic audit of Good Manufacturing Practices for cosmetics (ISO 22716).

Key-words
ISO22716 consulting implementation
Service Information
outros Segment
On demand (consulting) Delivery Format
geral@biosolve4all.com Contact

MDR Regulation and Compliance

Descrição

Consulting services for compliance with regulatory requirements (MDR/IVDR, Infarmed, EUDAMED).

Key-words
regulation MDR/IVDR ISO 13485
Service Information
outros Segment
Workshop / Training Delivery Format
geral@biosolve4all.com Contact