eu-mdr-gspr-mapper

Included with Lifetime

$97 forever

EU MDR General Safety and Performance Requirements (GSPR) mapping and compliance documentation skill

General

What this skill does


# EU MDR GSPR Mapper Skill

## Purpose

The EU MDR GSPR Mapper Skill facilitates compliance with the European Medical Device Regulation (MDR 2017/745) by mapping General Safety and Performance Requirements and generating comprehensive compliance documentation.

## Capabilities

- GSPR checklist generation by device classification
- Annex I requirement mapping
- Compliance evidence linkage
- Gap analysis reporting
- SSCP (Summary of Safety and Clinical Performance) drafting
- UDI-DI assignment assistance
- Technical documentation structure generation
- Harmonized standards cross-reference
- State of the art analysis support
- Risk-benefit analysis documentation
- Clinical evidence requirements mapping

## Usage Guidelines

### When to Use
- Preparing EU MDR technical documentation
- Conducting GSPR compliance assessments
- Drafting Summary of Safety and Clinical Performance
- Planning conformity assessment activities

### Prerequisites
- Device classification determined
- Applicable harmonized standards identified
- Risk management file available
- Clinical evaluation data compiled

### Best Practices
- Map all applicable GSPR requirements early in development
- Document evidence for each requirement systematically
- Maintain traceability between requirements and evidence
- Update documentation with regulatory changes

## Process Integration

This skill integrates with the following processes:
- EU MDR Technical Documentation
- Clinical Evaluation Report Development
- Post-Market Surveillance System Implementation
- Design Control Process Implementation

## Dependencies

- EUDAMED database integration
- MDR Annex templates
- Harmonized standards database
- MDCG guidance documents
- Notified body requirements

## Configuration

```yaml
eu-mdr-gspr-mapper:
  device-classes:
    - Class I
    - Class IIa
    - Class IIb
    - Class III
  documentation-types:
    - technical-documentation
    - sscp
    - declaration-of-conformity
  annex-sections:
    - chapter-i-general
    - chapter-ii-design-manufacture
    - chapter-iii-information
```

## Output Artifacts

- GSPR compliance checklists
- Requirement-to-evidence mapping
- Gap analysis reports
- SSCP drafts
- Technical documentation templates
- Harmonized standards matrices
- Compliance status dashboards

## Quality Criteria

- All applicable GSPR requirements identified
- Evidence mapping is complete and traceable
- Documentation meets Notified Body expectations
- Gap analysis identifies actionable items
- SSCP content meets MDR Article 32 requirements
- UDI assignments follow MDR Annex VI

Files: 1

Size: 2.9 KB

Complexity: 10/100

Category: General

Source: https://github.com/a5c-ai/babysitter/tree/main/library/specializations/domains/science/biomedical-engineering/skills/eu-mdr-gspr-mapper

Related in General

modeling-omnistudio-epc-catalog

Included

Salesforce Industries CME EPC product-modeling skill for Product2-based catalog creation. Use when creating EPC products, configuring product attributes, building offer bundles with Product Child Items, or reviewing EPC DataPack JSON metadata for product catalog changes. TRIGGER when: user creates or updates Product2 EPC records, AttributeAssignment payloads, AttributeMetadata/AttributeDefaultValues, Offer bundles, or ProductChildItem relationships. DO NOT TRIGGER when: designing OmniScripts/FlexCards/Integration Procedures (use building-omnistudio-omniscript, building-omnistudio-flexcard, or building-omnistudio-integration-procedure), implementing Apex business logic (use generating-apex), or troubleshooting deployment pipelines (use deploying-metadata).

Generalscripts

relationship-science-coach

Included

Use this skill for direct, practical adult relationship coaching: couples conflict, repair, trust, marriage, dating, flirting, attachment patterns, emotional connection, sex, desire differences, eroticism, kink negotiation, affection, love languages, breakups, and long-term passion. Draw on Gottman, EFT and Hold Me Tight, attachment science, modern sex research, Perel, Nagoski, Kerner, Schnarch, Love and Stosny, and flexible love-language tools. Be concrete and low-hedge. Redirect only for imminent danger, abuse, coercive control, minors, non-consent, self-harm, stalking, or medical/legal/psychiatric decisions.

Generalscripts

building-sf-integrations

Included

Salesforce integration architecture and runtime plumbing with 120-point scoring. Use this skill to set up Named Credentials, External Credentials, External Services, REST/SOAP callout patterns, Platform Events, and Change Data Capture. TRIGGER when: user sets up Named Credentials, External Services, REST/SOAP callouts, Platform Events, CDC, or touches .namedCredential-meta.xml files. DO NOT TRIGGER when: Connected App/OAuth config (use configuring-connected-apps), Apex-only logic (use generating-apex), or data import/export (use handling-sf-data).

Generalscripts

venue-templates

Included

Access comprehensive LaTeX templates, formatting requirements, and submission guidelines for major scientific publication venues (Nature, Science, PLOS, IEEE, ACM), academic conferences (NeurIPS, ICML, CVPR, CHI), research posters, and grant proposals (NSF, NIH, DOE, DARPA). This skill should be used when preparing manuscripts for journal submission, conference papers, research posters, or grant proposals and need venue-specific formatting requirements and templates.

Generalscripts

let-fate-decide

Included

Draws the 12 Houses of the Zodiac Tarot spread to inject entropy into planning when prompts are vague, ambiguous, or casually delegated. Interprets the spread to guide next steps. Use when the user says 'let fate decide', 'YOLO', 'whatever', 'idk', or other nonchalant phrases, makes Yu-Gi-Oh references, or when you are about to arbitrarily pick between multiple reasonable approaches. Prefer over ask-questions-if-underspecified when the user's tone is casual or playful rather than precision-seeking.

Generalscripts

net-ops

Included

Cross-platform network troubleshooting (Windows, macOS, Linux) via local or remote shell. Use for: DNS broken, can't resolve hostnames, nslookup/dig works but apps fail, NRPT, WFP, scutil, /etc/resolver, systemd-resolved, /etc/resolv.conf, NetworkManager, VPN DNS leak residue (ProtonVPN/Mullvad/WireGuard/AnyConnect), AV/firewall blocking DNS or DoH, Tailscale DNS interaction, intermittent connectivity, remote diagnostics over SSH.

Generalscripts