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Quality Management System implementation, revitalization and more.
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Quality management
Implementation and Revitalization of the Quality Management System.
Certificate of Good Manufacturing Practices.
Certificate of Good Distribution and Storage Practices.
ISO 13485 certification.
Treatment of non-conformities, Corrective Actions and Preventive Actions.
Critical Analysis of the Quality Management System.
Audit.
Certificate of Good Manufacturing Practices.
Certificate of Good Distribution and Storage Practices.
ISO 13485 certification.
Treatment of non-conformities, Corrective Actions and Preventive Actions.
Critical Analysis of the Quality Management System.
Audit.
Regulatory Requirements
Interpretation of regulatory requirements of national and international standards.
Adequacy of processes to meet standards.
Adequacy of Technical Dossier to meet requirements.
Adequacy of processes to meet standards.
Adequacy of Technical Dossier to meet requirements.
International Certifications
CE Mark Certification (MDD 93/42/EEC; MDR 2017/745)
FDA certification.
Worldwide registration of medical devices.
FDA certification.
Worldwide registration of medical devices.
Risk management
Risk Management Plan.
Risk Management Table.
Risk Management Report.
ISO 14971:2019
Usability Plan.
Usability Report.
ISO 62366
Risk Management Table.
Risk Management Report.
ISO 14971:2019
Usability Plan.
Usability Report.
ISO 62366
PMS/PSUR/PMCF
Post-Marketing Monitoring Plan.
Post-Market Monitoring Report
Post-Marketing Clinical Monitoring Plan.
Post-Marketing Clinical Monitoring Report.
MEDDEV 2.12-2, MDCGs, MDR 2017/745
Post-Market Monitoring Report
Post-Marketing Clinical Monitoring Plan.
Post-Marketing Clinical Monitoring Report.
MEDDEV 2.12-2, MDCGs, MDR 2017/745
Clinical Assessment
Clinical Assessment Plan
Clinical Assessment Report
MEDDEV 2.7.1/4; MDCG 2020-5; MDCG 2020-6; MDD 93/42/EEC; MDR 2017/745
Clinical Assessment Report
MEDDEV 2.7.1/4; MDCG 2020-5; MDCG 2020-6; MDD 93/42/EEC; MDR 2017/745
Clinical Research
Clinical Investigation Protocol
Free and Informed Consent Form
Search Form
Submission on the Brazil Platform
CNS 466:2012; RDC 548:2021; ISO 14155:2020
Free and Informed Consent Form
Search Form
Submission on the Brazil Platform
CNS 466:2012; RDC 548:2021; ISO 14155:2020
Raw Material Registration
Registration with the European Directorate for the Quality of Medicines (EDQM)
Biological Assessment / Biocompatibility
Biological Assessment Plan
Biological Assessment Report
Toxicological Risk Assessment Report
ISO 10993
Biological Assessment Report
Toxicological Risk Assessment Report
ISO 10993
Validations
Sterilization Validation Plan.
Sterilization Validation Report.
Sterile barrier validation plan.
Sterile barrier validation report.
Cleaning Validation Protocol for the production area.
Cleaning Validation Report for the production area.
Medical product cleaning validation protocol.
Medical product cleaning validation report.
Transport Validation Protocol.
Transport Validation Report.
Accelerated Stability Study Protocol (Shelf-Life).
Accelerated Stability Study Report (Shelf-Life).
Stability Study Protocol (Shelf-Life) in Real Time
Stability Study Report (Shelf-Life) in Real Time.
Sterilization Validation Report.
Sterile barrier validation plan.
Sterile barrier validation report.
Cleaning Validation Protocol for the production area.
Cleaning Validation Report for the production area.
Medical product cleaning validation protocol.
Medical product cleaning validation report.
Transport Validation Protocol.
Transport Validation Report.
Accelerated Stability Study Protocol (Shelf-Life).
Accelerated Stability Study Report (Shelf-Life).
Stability Study Protocol (Shelf-Life) in Real Time
Stability Study Report (Shelf-Life) in Real Time.
Courses / Training
Good Manufacturing Practices - RDC 665:2022
Quality Management System - ISO 13485:2016
CE Marking - European Regulation 2017/745
Biological Assessment - ISO 10993-1
Post-market Monitoring - RDC 665:2022, European Regulation 2017/745 and MDCGs
Medical Product Registration at ANVISA
Clinical Assessment - MEDDEV 2.7/1-4 and MDR 2017/745.
Quality Management System - ISO 13485:2016
CE Marking - European Regulation 2017/745
Biological Assessment - ISO 10993-1
Post-market Monitoring - RDC 665:2022, European Regulation 2017/745 and MDCGs
Medical Product Registration at ANVISA
Clinical Assessment - MEDDEV 2.7/1-4 and MDR 2017/745.
Quality management
Implementation and Revitalization of the Quality Management System.
Certificate of Good Manufacturing Practices.
Certificate of Good Distribution and Storage Practices.
ISO 13485 certification.
Treatment of non-conformities, Corrective Actions and Preventive Actions.
Critical Analysis of the Quality Management System.
Audit.
Certificate of Good Manufacturing Practices.
Certificate of Good Distribution and Storage Practices.
ISO 13485 certification.
Treatment of non-conformities, Corrective Actions and Preventive Actions.
Critical Analysis of the Quality Management System.
Audit.
Regulatory Requirements
Interpretation of regulatory requirements of national and international standards.
Adequacy of processes to meet standards.
Adequacy of Technical Dossier to meet requirements.
Adequacy of processes to meet standards.
Adequacy of Technical Dossier to meet requirements.
International Certifications
CE Mark Certification (MDD 93/42/EEC; MDR 2017/745)
FDA certification.
Worldwide registration of medical devices.
FDA certification.
Worldwide registration of medical devices.
Risk management
Risk Management Plan.
Risk Management Table.
Risk Management Report.
ISO 14971:2019
Usability Plan.
Usability Report.
ISO 62366
Risk Management Table.
Risk Management Report.
ISO 14971:2019
Usability Plan.
Usability Report.
ISO 62366
PMS/PSUR/PMCF
Post-Marketing Monitoring Plan.
Post-Market Monitoring Report
Post-Marketing Clinical Monitoring Plan.
Post-Marketing Clinical Monitoring Report.
MEDDEV 2.12-2, MDCGs, MDR 2017/745
Post-Market Monitoring Report
Post-Marketing Clinical Monitoring Plan.
Post-Marketing Clinical Monitoring Report.
MEDDEV 2.12-2, MDCGs, MDR 2017/745
Clinical Assessment
Clinical Assessment Plan
Clinical Assessment Report
MEDDEV 2.7.1/4; MDCG 2020-5; MDCG 2020-6; MDD 93/42/EEC; MDR 2017/745
Clinical Assessment Report
MEDDEV 2.7.1/4; MDCG 2020-5; MDCG 2020-6; MDD 93/42/EEC; MDR 2017/745
Clinical Research
Clinical Investigation Protocol
Free and Informed Consent Form
Search Form
Submission on the Brazil Platform
CNS 466:2012; RDC 548:2021; ISO 14155:2020
Free and Informed Consent Form
Search Form
Submission on the Brazil Platform
CNS 466:2012; RDC 548:2021; ISO 14155:2020
Raw Material Registration
Registration with the European Directorate for the Quality of Medicines (EDQM)
Biological Assessment / Biocompatibility
Biological Assessment Plan
Biological Assessment Report
Toxicological Risk Assessment Report
ISO 10993
Biological Assessment Report
Toxicological Risk Assessment Report
ISO 10993
Validations
Sterilization Validation Plan.
Sterilization Validation Report.
Sterile barrier validation plan.
Sterile barrier validation report.
Cleaning Validation Protocol for the production area.
Cleaning Validation Report for the production area.
Medical product cleaning validation protocol.
Medical product cleaning validation report.
Transport Validation Protocol.
Transport Validation Report.
Accelerated Stability Study Protocol (Shelf-Life).
Accelerated Stability Study Report (Shelf-Life).
Stability Study Protocol (Shelf-Life) in Real Time
Stability Study Report (Shelf-Life) in Real Time.
Sterilization Validation Report.
Sterile barrier validation plan.
Sterile barrier validation report.
Cleaning Validation Protocol for the production area.
Cleaning Validation Report for the production area.
Medical product cleaning validation protocol.
Medical product cleaning validation report.
Transport Validation Protocol.
Transport Validation Report.
Accelerated Stability Study Protocol (Shelf-Life).
Accelerated Stability Study Report (Shelf-Life).
Stability Study Protocol (Shelf-Life) in Real Time
Stability Study Report (Shelf-Life) in Real Time.
Courses / Training
Good Manufacturing Practices - RDC 665:2022
Quality Management System - ISO 13485:2016
CE Marking - European Regulation 2017/745
Biological Assessment - ISO 10993-1
Post-market Monitoring - RDC 665:2022, European Regulation 2017/745 and MDCGs
Medical Product Registration at ANVISA
Clinical Assessment - MEDDEV 2.7/1-4 and MDR 2017/745.
Quality Management System - ISO 13485:2016
CE Marking - European Regulation 2017/745
Biological Assessment - ISO 10993-1
Post-market Monitoring - RDC 665:2022, European Regulation 2017/745 and MDCGs
Medical Product Registration at ANVISA
Clinical Assessment - MEDDEV 2.7/1-4 and MDR 2017/745.
Quality management
Implementation and Revitalization of the Quality Management System.
Certificate of Good Manufacturing Practices.
Certificate of Good Distribution and Storage Practices.
ISO 13485 certification.
Treatment of non-conformities, Corrective Actions and Preventive Actions.
Critical Analysis of the Quality Management System.
Audit.
Certificate of Good Manufacturing Practices.
Certificate of Good Distribution and Storage Practices.
ISO 13485 certification.
Treatment of non-conformities, Corrective Actions and Preventive Actions.
Critical Analysis of the Quality Management System.
Audit.
Regulatory Requirements
Interpretation of regulatory requirements of national and international standards.
Adequacy of processes to meet standards.
Adequacy of Technical Dossier to meet requirements.
Adequacy of processes to meet standards.
Adequacy of Technical Dossier to meet requirements.
International Certifications
CE Mark Certification (MDD 93/42/EEC; MDR 2017/745)
FDA certification.
Worldwide registration of medical devices.
FDA certification.
Worldwide registration of medical devices.
Risk management
Risk Management Plan.
Risk Management Table.
Risk Management Report.
ISO 14971:2019
Usability Plan.
Usability Report.
ISO 62366
Risk Management Table.
Risk Management Report.
ISO 14971:2019
Usability Plan.
Usability Report.
ISO 62366
PMS/PSUR/PMCF
Post-Marketing Monitoring Plan.
Post-Market Monitoring Report
Post-Marketing Clinical Monitoring Plan.
Post-Marketing Clinical Monitoring Report.
MEDDEV 2.12-2, MDCGs, MDR 2017/745
Post-Market Monitoring Report
Post-Marketing Clinical Monitoring Plan.
Post-Marketing Clinical Monitoring Report.
MEDDEV 2.12-2, MDCGs, MDR 2017/745
Clinical Assessment
Clinical Assessment Plan
Clinical Assessment Report
MEDDEV 2.7.1/4; MDCG 2020-5; MDCG 2020-6; MDD 93/42/EEC; MDR 2017/745
Clinical Assessment Report
MEDDEV 2.7.1/4; MDCG 2020-5; MDCG 2020-6; MDD 93/42/EEC; MDR 2017/745
Clinical Research
Clinical Investigation Protocol
Free and Informed Consent Form
Search Form
Submission on the Brazil Platform
CNS 466:2012; RDC 548:2021; ISO 14155:2020
Free and Informed Consent Form
Search Form
Submission on the Brazil Platform
CNS 466:2012; RDC 548:2021; ISO 14155:2020
Raw Material Registration
Registration with the European Directorate for the Quality of Medicines (EDQM)
Biological Assessment / Biocompatibility
Biological Assessment Plan
Biological Assessment Report
Toxicological Risk Assessment Report
ISO 10993
Biological Assessment Report
Toxicological Risk Assessment Report
ISO 10993
Validations
Sterilization Validation Plan.
Sterilization Validation Report.
Sterile barrier validation plan.
Sterile barrier validation report.
Cleaning Validation Protocol for the production area.
Cleaning Validation Report for the production area.
Medical product cleaning validation protocol.
Medical product cleaning validation report.
Transport Validation Protocol.
Transport Validation Report.
Accelerated Stability Study Protocol (Shelf-Life).
Accelerated Stability Study Report (Shelf-Life).
Stability Study Protocol (Shelf-Life) in Real Time
Stability Study Report (Shelf-Life) in Real Time.
Sterilization Validation Report.
Sterile barrier validation plan.
Sterile barrier validation report.
Cleaning Validation Protocol for the production area.
Cleaning Validation Report for the production area.
Medical product cleaning validation protocol.
Medical product cleaning validation report.
Transport Validation Protocol.
Transport Validation Report.
Accelerated Stability Study Protocol (Shelf-Life).
Accelerated Stability Study Report (Shelf-Life).
Stability Study Protocol (Shelf-Life) in Real Time
Stability Study Report (Shelf-Life) in Real Time.
Courses / Training
Good Manufacturing Practices - RDC 665:2022
Quality Management System - ISO 13485:2016
CE Marking - European Regulation 2017/745
Biological Assessment - ISO 10993-1
Post-market Monitoring - RDC 665:2022, European Regulation 2017/745 and MDCGs
Medical Product Registration at ANVISA
Clinical Assessment - MEDDEV 2.7/1-4 and MDR 2017/745.
Quality Management System - ISO 13485:2016
CE Marking - European Regulation 2017/745
Biological Assessment - ISO 10993-1
Post-market Monitoring - RDC 665:2022, European Regulation 2017/745 and MDCGs
Medical Product Registration at ANVISA
Clinical Assessment - MEDDEV 2.7/1-4 and MDR 2017/745.
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