Safety Management for Medical Device and IVD studies
Structured safety oversight for medical device and IVD studies – built on ISO, MDR/IVDR, and MDCG compliance.
GBA Key2Compliance offers end-to-end Safety Management for clinical investigations and performance studies, covering medical devices and IVDs. Our process is aligned with ISO 14155, ISO20916, and the latest MDCG guidance for safety reporting in clinical studies.
We support sponsors with structured processes to capture, assess, report, and document safety events – from adverse event handling to authority reporting and safety data reconciliation.
Our Safety Management Services Include
- Development of study-specific Safety Management Plans (SMP)
- Safety input to CIP or CPSP and eCRF design
- Surveillance and handling of AEs and device deficiencies (DDs)
- Coordination with Medical Monitor for causality assessment and coding
- Regulatory reporting to Ethics Committees and Competent Authorities
- Coding using MedDRA, IMDRF and WHO-ATC dictionaries
- Maintenance and reconciliation of safety database
- Oversight of DSMBs and Endpoint Adjudication Committees
- Training and guidance for site staff and sponsor-appointed roles
- Full documentation and audit trail management
How We Work
- Safety management is delivered by a dedicated Safety Manager with backup, mailbox surveillance, and escalation paths in place.
- We tailor each study’s safety setup based on its risk level, regulatory pathway, and sponsor’s internal setup.
- For high-risk or complex studies, we support the setup of DSMBs and Endpoint Committees, including charters and operational documentation.