Key2Compliance
GBA Key2Compliance makes complex regulatory, quality, and clinical development processes easier for Medical Device, IVD, and Pharma companies. With over 70 professionals, they offer expert consulting and specialized training, focusing on compliance, innovation, and patient safety. As part of GBA Group since January 16, 2024, they expand their service offerings and global reach, providing comprehensive support from preclinical development to market release and quality assurance.
Industries
Nr. of Employees
small (1-50)
Key2Compliance
Stockholm, Stockholms Lan, Sweden, Europe
Products
AI-based device classification tool
Online classifier to assist in determining medical device risk classification under MDR/IVDR.
Guide: Clinical Investigation Plans & Reports
Downloadable guide offering step-by-step instructions to develop Clinical Investigation Plans and Reports compliant with MDR and ISO 14155.
Training catalogue and public courses
Catalogue of public, in‑house and on‑demand courses covering QMS, sterilization, risk management, auditing, MDSAP, CAPA, supplier control and other regulatory topics.
Knowledge tests and training tools (webshop)
Online knowledge tests and training tools available for purchase to support learning and competency assessment.
AI-based device classification tool
Online classifier to assist in determining medical device risk classification under MDR/IVDR.
Guide: Clinical Investigation Plans & Reports
Downloadable guide offering step-by-step instructions to develop Clinical Investigation Plans and Reports compliant with MDR and ISO 14155.
Training catalogue and public courses
Catalogue of public, in‑house and on‑demand courses covering QMS, sterilization, risk management, auditing, MDSAP, CAPA, supplier control and other regulatory topics.
Knowledge tests and training tools (webshop)
Online knowledge tests and training tools available for purchase to support learning and competency assessment.
Services
Regulatory strategy, submission preparation, notified body liaison, CE-marking support and regulatory maintenance for MDR/IVDR and other international markets.
End-to-end clinical study services including protocol development, study execution, monitoring, data management, eTMF support and clinical reporting aligned with ISO 14155.
QMS creation, process definition, internal audits, CAPA, supplier control and transition support to electronic QMS platforms.
Biological evaluation planning and execution, toxicological risk assessments and support for preclinical and analytical performance evaluations.
Support for GMP/GCP/GLP/GDP/GVP compliance, GMP inspection preparedness, validation and qualification, and cleaning validation.
Regulatory, quality and technical training delivered as public courses, in-house workshops or on-demand e-learning covering topics such as QMS, risk management, clinical evaluation and sterilization.
Regulatory strategy, submission preparation, notified body liaison, CE-marking support and regulatory maintenance for MDR/IVDR and other international markets.
End-to-end clinical study services including protocol development, study execution, monitoring, data management, eTMF support and clinical reporting aligned with ISO 14155.
QMS creation, process definition, internal audits, CAPA, supplier control and transition support to electronic QMS platforms.
Biological evaluation planning and execution, toxicological risk assessments and support for preclinical and analytical performance evaluations.
Support for GMP/GCP/GLP/GDP/GVP compliance, GMP inspection preparedness, validation and qualification, and cleaning validation.
Regulatory, quality and technical training delivered as public courses, in-house workshops or on-demand e-learning covering topics such as QMS, risk management, clinical evaluation and sterilization.
Expertise Areas
- Regulatory compliance for medical devices and IVDs (MDR/IVDR)
- Clinical trial management and clinical evaluation
- Quality Management Systems (ISO 13485) and QMS implementation
- Pharmaceutical GxP compliance and GMP readiness
Key Technologies
- IEC 60601 electrical safety standards
- IEC 62304 software lifecycle processes
- IEC 61010 laboratory equipment safety
- ISO 13485 quality management standard
News & Updates
An article explaining the complexities of medical devices and the importance of regulatory compliance.
A story about the team’s expertise and a workshop on photography.
An article on clinical evidence building for medical devices.
Insights into maintaining clinical studies.
Details about the PRRC role introduced by MDR and IVDR, and how GBA Key2Compliance supports companies in meeting these requirements.
Discussion on leadership, ownership, and accountability in medical device quality management.
An article explaining the complexities of medical devices and the importance of regulatory compliance.
A story about the team’s expertise and a workshop on photography.
An article on clinical evidence building for medical devices.
Insights into maintaining clinical studies.
Details about the PRRC role introduced by MDR and IVDR, and how GBA Key2Compliance supports companies in meeting these requirements.
Discussion on leadership, ownership, and accountability in medical device quality management.