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| Template Name | Description | Link |
|---|---|---|
| MDCG 2020-10/2 document is titled: "Guidance on safety reporting in clinical investigations of medical devices under the MDR – Reporting Form | This guidance was published by the Medical Device Coordination Group (MDCG) to support sponsors and investigators in reporting serious adverse events (SAEs), device deficiencies, and other safety-related findings that occur during clinical investigations under the EU Medical Devices Regulation (EU) 2017/745 (MDR). The Excel sheet that comes with MDCG 2020-10/2 is a standardized template to report safety events. It is designed to ensure harmonized and complete reporting to national competent authorities (NCAs). | Click Here |
| 510k Submission | A set of standardized tabular templates has been developed for each section of the FDA 510(k) submission. These templates are designed in alignment with applicable FDA guidance documents, enabling medical device manufacturers to efficiently compile and present required information. | Click Here |
| Document Name | Description | Link |
|---|---|---|
| MDD to MDR Gap Analysis | This resource outlines a comprehensive gap analysis between the Medical Device Directive (MDD) to Medical Device Regulation (MDR). The analysis serves as a valuable tool for manufacturers transitioning to MDR compliance, ensuring alignment with updated EU regulatory requirements and improving readiness for Notified Body assessments. | Click Here |
| IVDD to IVDR- Gap Analysis | This resource outlines a comprehensive gap analysis between the In Vitro Diagnostic Directive (IVDD) to In Vitro Diagnostic Regulation (IVDR). The analysis serves as a valuable tool for manufacturers transitioning to IVDR compliance, ensuring alignment with updated EU regulatory requirements and improving readiness for Notified Body assessments. | Click Here |