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| Template Name | Description | Link |
|---|---|---|
| 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 |