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    • GP-001 Documents and records control
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        • R-001-001 Control of documents and records
        • R-001-001 Control of documents and records_2023_001
        • R-001-001 Control of documents and records 2023_002
        • R-001-001 Control of documents 2023_003
        • R-001-001 Control of documents 2023_003
        • R-001-002 2020_001 Manufacturer declaration of conformity
        • R-001-002 2021_001 Manufacturer declaration of conformity
        • R-001-002 2021_002 Manufacturer declaration of conformity
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        • R-001-002 2021_004 Manufacturer declaration of conformity
        • R-001-002 2023_001 Manufacturer declaration of conformity
        • R-001-002 Manufacturer declaration of conformity_2023_002
        • R-001-003 Backup copies control
        • R-001-004 Backup integrity verification
        • R-001-005 List of external documents_2023_001
        • R-001-005 List of external documents_2023_002
        • R-001-005 List of external documents_2023_003
        • R-001-005 List of external documents_2023_004
      • R-001-001 Control of documents
      • R-001-002 Manufacturer declaration of conformity for Brazil
      • R-001-002 Manufacturer declaration of conformity
      • R-001-005 List of external documents
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      • R-001-009 Training on procedures of the QMS
      • R-001-009 Training on procedures of the QMS
      • R-001-009 Training on procedures of the QMS
      • R-001-009 Training on procedures of the QMS
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  • GP-001 Documents and records control
  • Deprecated
  • R-001-005 List of external documents_2023_001

R-001-005 List of external documents_2023_001

  • Governed by GP-001 Document and Registry Control
  • Comes from template T-001-005

Version control​

Reason for reviewDateVersion id
First version202301271
Written byReviewed by

E-Signature (Appfire integration):

Signature logo

María Diez

BC8BB89A5A502F2AD8C639970D984645

Signer name: María Diez

Signing time: Thu, 26 Jan 2023 13:20:43 GMT

Reason: Creation of document

E-Signature (Appfire integration):

Signature logo

Alfonso Medela

16434E53E6324722E53B2288E08237FE

Signer name: Alfonso Medela

Signing time: Fri, 27 Jan 2023 13:19:51 GMT

Reason: Reviewed

Quality manager (QM)Technical manager (PRRC)

External documents archive​

External documents are compiled at the GoogleDrive workspace: https://drive.google.com/drive/folders/1XtUaSvT0yzhfuIUyFhXUiqZxHpNVkz3d They are organized in folders regarding their main related issue. The following tables list all the documents compiled, one table per folder.

AEMPS & CNCPS​

NameSourceVersionDateImpact?
Instrucción PS1/2022 sobre el procedimiento de licencia previa de funcionamiento de instalaciones de productos sanitariosAEMPSPS 1/202204/01/2022No
R_DEX_18_Guía para la elaboración de la documentación técnica: Marcado CE MDRCNCPS202206/27/2022Yes. TF being prepared
CERTPS-ManualEmpresa: Certificado de libre ventaAEMPS2.1.0Yes. Certificate application submited

CFR_FDA​

NameSourceVersionDateImpact?
Guidance Computer Software Assurance for production and Quality System SoftwareFDA202209/13/2022No
Guidance for Industry. Part 11, Electronic Records; Electronic SignaturesFDA08/2023

Clinical studies​

NameSourceVersionDateImpact?
Guideline for good clinical practice E6 (R2) Step 5EMA/ICHE6 (R2)06/14/2017

EU Medical devices​

NameSourceVersionDateImpact?
Directive 93/42/EEC concerning medical devicesEuropean CommissionM510/11/2007No
Regulation 2017/745 on medical devicesEuropean CommissionM104/24/2020Yes. Adaptation proccess in progress
Regulation 2017/2185 related to codes and medical devicesEuropean Commission11/24/2017No
Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisionsEuropean Commission2023/000501/06/2023No
Manufacturer incident report (MIR)European Commission7.2.1No

Guides​

MDCG guidelines can be downloaded on their last version from the European Commission webpage (https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en).

MedDev guidelines can be consulted and downloaded on their last version from the European Commission webpage.

In the following table we have compile some of these guidelines that we have consulted during the medical device documentation preparation:

NameSourceVersionDateImpact?
Manual on borderline and classification in the community regulatory framework for medical devices1.2205/2019No
Additional guidance regarding the vigilance system as outlined in MEDDEV 2.12-1 rev.8European Commission807/10/2019No
MDCG 2020-5 Clinical evaluation - EquivanceMDCG004/2020No
MDCG 2020-7 PMCF plan templateMDCG004/2020No
MDCG-2020-8 PMCF evaluation report templateMDCG004/2020No
MDCG-2020-1 Guidance con clinical evaluation of MD softwareMDCG003/2020No
MDCG 2022-4 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regar to devices covered by certificates according to the MDD or the AIMDDMDCG112/2022No
MDCG 2022-2021 Guidance on PSUR according to regulation (EU) 2017/745 (MDR)MDCG012/2022No
MDCG 2023-3 Questions and answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devicesMDCG002/2023No
Meddev 2.12-1 Guidelines on a medical devices vigilance systemEuropean Commission801/2013No
Meddev 2.1/6 Guidelines on the qualification and classification of stand alone software used in thealthcare within the regulatory framework of medical devicesEuropean Commission007/2016No
Meddev 2.7/1 Guidelines on medical devicesEuropean Commission406/2016No

Quality Regulations​

NameSourceVersionDateImpact?
ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposesISOE03/01/2016
ISO 62304 :2006 Software de dispositivos médicos. Procesos del ciclo de vida del softwareAENOR03/2007
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All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)