Plugins
2 plugins@alirezarezvani
Ra Qm Team
14 regulatory affairs & quality management skills for HealthTech/MedTech: ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, GDPR/DSGVO, ISO 27001 ISMS, CAPA management, risk management, clinical evaluation, SOC 2 compliance.
10 skills · plugin
@alirezarezvani
Compliance Os
Compliance OS — meta-orchestrator for multi-framework compliance programs spanning 9 frameworks (ISO 27001, ISO 13485, ISO 42001, ISO 14971, EU AI Act, MDR 745, GDPR, SOC 2, FDA QSR). Framework selector, cross-framework control mapper, audit simulator, and consolidated evidence-pool generator (stdlib Python), plus 3 cs-* compliance agents and 3 /cs:* readiness commands.
9 skills · plugin
Results for “iso-13485”
15 skills
More results
neekware quality-manager-qmr
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.
0 · bundle
bytesagain iso
ISO standard compliance checker
12 · bundle
mukul975-2 gdpr-certification
Guides implementation of GDPR Article 42-43 data protection certification mechanisms including accredited certification bodies, criteria development, and periodic review. Activate when pursuing privacy certifications, evaluating certification bodies, or developing certification criteria. Keywords: certification, Article 42, Article 43, accreditation, seal, privacy mark.
228 · bundle
tools-only 155-zero-0a870ee6
Defines quality standards and validation checklists for agent workflows, Python tools, and documentation, including automated checks and pre-commit gates.
7 · bundle
mukul975 implementing-ot-incident-response-playbook
Develop and implement OT-specific incident response playbooks aligned with SANS PICERL framework, IEC 62443, and NIST SP 800-82 that address unique ICS challenges including safety-critical systems, limited downtime tolerance, and coordination between IT SOC, OT engineering, and plant operations teams.
24.6k · bundle
affaan-m cpp-coding-standards
Enforces modern, safe, and idiomatic C++ coding practices based on the C++ Core Guidelines for writing, reviewing, or refactoring C++ code.
226k
ssrjkk ai-safety
AI safety and responsible AI practices
2 · bundle
beriberikix hardware-io
Hardware interfacing and peripheral management for Zephyr RTOS. Covers the sensor subsystem (channels, triggers, fetch/get), pin control (Pinctrl) and multiplexing, GPIO management using Devicetree specs, and SoC-level hardware configurations. Trigger when adding new hardware components, configuring pinmux, or developing sensor-based applications.
60 · bundle
comeonoliver harden
Strengthen interfaces against edge cases, errors, internationalization issues, and real-world usage scenarios that break idealized designs.
61
snoodleboot-io incremental-implementation
Comprehensive guide for implementing code incrementally following established patterns, conventions, and quality standards
2
beriberikix industrial
Industrial communication protocols for Zephyr RTOS. Covers Modbus RTU (serial), Modbus TCP (Ethernet/Wi-Fi), and CANopen basics. Trigger when building factory automation controllers, industrial sensors, or medical equipment interfaces.
60 · bundle
kk20300113-png kotlin-patterns
Idiomatic Kotlin patterns, best practices, and conventions for building robust, efficient, and maintainable Kotlin applications with coroutines, null safety, and DSL builders.
0
rajanthar kotlin-patterns
Enforces idiomatic Kotlin conventions for null safety, immutability, sealed classes, coroutines, extension functions, DSL builders, and Gradle Kotlin DSL.
0
mmehdi0606 harden
Strengthen interfaces against edge cases, errors, internationalization issues, and real-world usage scenarios that break idealized designs.
2