ISO Compliance
Achieving ISO compliance strengthens organizational efficiency, builds global regulatory credibility, and enhances market competitiveness for medical device manufacturers. At Realistic Quality Solutions (RQS), we design robust, scalable QMS frameworks that ensure compliance with ISO 9001, ISO 13485, and MDSAP regulatory standards, allowing seamless international market entry.
Core ISO Standards & Regulatory Compliance Support:
- ISO 9001:2015 – Quality Management for Business Excellence
- ISO 13485:2016 – Medical Device-Specific Quality Management
- Medical Device Single Audit Program (MDSAP) – Global Compliance Alignment
- Global Medical Device Regulatory Compliance & CE Mark Submissions
RQS ensures seamless market entry in Europe by guiding organizations from EU MDD (Medical Device Directive) to EU MDR (Medical Device Regulation) compliance. This is accomplished via:
- Technical File Development & Maintenance
- CE Mark Submission & Regulatory Filing
Strategic Benefits of ISO Certification & Global Compliance:
- Expanding Business Opportunities & Market Access
- Reciprocal Compliance Recognition for Multi-Regional Expansion
- Strengthening Operational Integrity & Industry Leadership
- Optimizing Risk Management & Audit Preparedness
Once your quality system is in place, RQS will help you select a registrar or certifying body and will help you through your registration audit and ensuing surveillance audits. RQS will also be able to help you register your products in those countries where you do business.
End-to-End ISO Compliance Implementation & Certification Support via:
- Quality System Design & Strategic Implementation
- Certification & Registration Support
- Post-Certification Compliance & Regulatory Lifecycle Management
With Realistic Quality Solutions (RQS), your organization secures a structured, sustainable compliance framework, enabling efficient operations, continuous regulatory success, and global market expansion.
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