CRO Group
The CRO Group is a leading global consulting organization and service provider specializing in regulatory, clinical, and quality services for medical device, IVD, OTC, Digital Health, SaMD, and Wearable product companies. They support FDA approvals, CE Marking, clinical studies, ISO 13485:2016, MDSAP, ISO 14971, IEC 62304, and other compliance needs, leveraging their strategic locations and extensive network to assist clients worldwide.
Industries
Nr. of Employees
small (1-50)
Services
Consulting to prepare and submit premarket applications (510(k), PMA, IDE, De Novo, 513(g)) and CE technical files/design dossiers, including coordination with notified bodies and regulatory authorities.
Turnkey implementation and documentation support for ISO 13485:2016, MDSAP readiness, and US QSR compliance including preparation for Stage I assessments.
Protocol development, site and investigator selection, patient recruitment, monitoring, and independent auditing for premarket and post-market clinical studies compliant with ICH-GCP, FDA and EU requirements.
Support across the software development lifecycle for medical device software and SaMD including SDLC planning, risk management, coding/testing integration, and preparation of IEC 62304/ISO 12207 documentation.
Internal, supplier, pre-audit and mock FDA/Notified Body inspections as well as due diligence audits for acquisitions and investment reviews.
Design review, test plan preparation and test-lab selection support for electrical safety (IEC 60601 series) and EMC testing to reduce re-testing and design iteration.
Consulting to prepare and submit premarket applications (510(k), PMA, IDE, De Novo, 513(g)) and CE technical files/design dossiers, including coordination with notified bodies and regulatory authorities.
Turnkey implementation and documentation support for ISO 13485:2016, MDSAP readiness, and US QSR compliance including preparation for Stage I assessments.
Protocol development, site and investigator selection, patient recruitment, monitoring, and independent auditing for premarket and post-market clinical studies compliant with ICH-GCP, FDA and EU requirements.
Support across the software development lifecycle for medical device software and SaMD including SDLC planning, risk management, coding/testing integration, and preparation of IEC 62304/ISO 12207 documentation.
Internal, supplier, pre-audit and mock FDA/Notified Body inspections as well as due diligence audits for acquisitions and investment reviews.
Design review, test plan preparation and test-lab selection support for electrical safety (IEC 60601 series) and EMC testing to reduce re-testing and design iteration.
Expertise Areas
- Regulatory submissions and CE marking
- Quality management systems (ISO 13485, MDSAP, QSR)
- Clinical trial design, monitoring and post-market studies
- Software development lifecycle for medical devices and SaMD
Key Technologies
- IEC 62304-compliant SDLC
- IEC 60601 electrical safety standards
- EMC testing (radiated/conducted emissions and immunity)
- ISO 13485 quality management
News & Updates
FDA revised and issued 'Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors'. This guidance supersedes the 1998 version and updates draft guidance from July.
The CRO Group announces its return after three years, reflecting on changes and ongoing developments in the industry.
The EU Medical Device Coordination Group released guidance on qualification and classification of software under MDR/IVDR regulations.
The Australian TGA issued guidance on electronic instructions for use (eIFU) for medical devices, including requirements for version control and accessibility.
Discussion on the transition from R&TTE Directive to new regulations for legacy CE Marked medical devices emitting RF.
FDA revised and issued 'Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors'. This guidance supersedes the 1998 version and updates draft guidance from July.
The CRO Group announces its return after three years, reflecting on changes and ongoing developments in the industry.
The EU Medical Device Coordination Group released guidance on qualification and classification of software under MDR/IVDR regulations.
The Australian TGA issued guidance on electronic instructions for use (eIFU) for medical devices, including requirements for version control and accessibility.
Discussion on the transition from R&TTE Directive to new regulations for legacy CE Marked medical devices emitting RF.