ISO 13485:2016
Quality management systems for medical devices. The international standard for organizations involved in design, production, installation, and servicing of medical devices.
- Full clause-by-clause analysis
- Design control requirements
- Risk management integration
FDA QMSR
FDA Quality Management System Regulation (21 CFR Part 820). The updated framework harmonizing FDA requirements with ISO 13485 for medical device manufacturers.
- QMSR transition support
- DHF/DMR/DHR requirements
- CAPA and complaint handling
EU MDR 2017/745
European Medical Device Regulation. Comprehensive regulatory framework for medical devices placed on the EU market, including technical documentation requirements.
- Annex I General Safety requirements
- Technical documentation review
- Post-market surveillance
AS9100D
Quality management system standard for aviation, space, and defense industries. Based on ISO 9001 with additional aerospace-specific requirements.
- Operational risk management
- Configuration management
- Product safety requirements
ISO 9001:2015
International standard for quality management systems. Applicable to any organization regardless of size or industry, focusing on customer satisfaction and continuous improvement.
- Process approach analysis
- Risk-based thinking
- Leadership and planning
ISO 14971:2019
Risk management for medical devices. The international standard for identifying, evaluating, and controlling risks associated with medical devices throughout their lifecycle.
- Risk identification and analysis
- Risk control measures review
- Risk management file completeness
MDSAP
Medical Device Single Audit Program. A single regulatory audit covering requirements from multiple regulatory jurisdictions including US, Canada, Australia, Brazil, and Japan.
- Multi-jurisdiction coverage
- Audit model alignment
- Companion document analysis
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