Quality Systems

We provide made to measure quality system solutions that are tailored to your organization and requirement. Amongst the various premarket and post-market quality systems support that Xplore has provided, the following have been the most popular ones:

• Quality systems setup (ISO 13485:2016/QSR/MDSAP)
• 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