Quality systems are all about the rigor and discipline needed to ensure continuous improvement, compliance and product consistency.

RAAJ GPRAC ensure that your employees and partners adhere to requirements by means of a global quality management system and can also advise on special-purpose quality management systems for clinical laboratories, R&D facilities or design houses.

Our medical device quality management system expertise helps you follow best practices, adhere to global compliance requirements and adopt a streamlined, consistent approach to managing the system. Whether for ISO 13485 or the FDA’s Medical Device Single Audit Program or 21 CFR 820 FDA QSR compliance, our team can support any medical device or diagnostic project need.

We provide made to measure quality system solutions that are customized to your organization and requirement.

• Quality systems setup (ISO 13485:2016/QSR/MDSAP)
• Comprehensive multi-site and multi-scope audit services, including areas for improvement
• Validation of various software involved in the QMS
• Document Controller appointment
• Internal Audit
• Training sessions for ISO 13485:2016, MDSAP, IEC 62304, ISO 14971
• Supplier audits & monitoring
• Managing external parties for mergers, acquisitions, and deals
• FDA inspection
• Gap assessments
• Unique Device Identification (UDI)
• CAPA management
• Annual renewal of company’s registration
• Global Quality System Development, Implementation and Certification (ISO 9001:2015 / ISO 13485:2016 / US FDA QSR / CMDR / JPAL / MDD / GMP / CFR)
• Annual renewal of listing & agents
• Complaint handling & reporting