Quality Management Systems for Medtech
100%
CDSCO audit pass rate
ISO 13485
Certified QMS frameworks
Schedule V
MDR 2017 compliance
Artexa guides medical device companies through every stage of quality system implementation, audit preparation, and notified body interactions.
ISO 13485 Compliance
MDR 2017 Fifth Schedule
Pre & Post Audit Support
End-to-end quality system establishment, documentation architecture, and certification preparation customized for medical device manufacturers.
Rigorous alignment of manufacturing facilities and quality processes with the mandatory Fifth Schedule requirements of Indian MDR 2017.
Comprehensive pre-assessment readiness checks, document verifications, and post-audit corrective and preventive action (CAPA) closure.
Notified Body Liaison
CDSCO Mock Audits
ISO 13485 Mock Audits
Strategic identification of registered Notified Bodies and hands-on liaisoning to streamline your audit scheduling and certification issuance.
Simulated regulatory inspections replicating official CDSCO audit protocols to uncover gaps before formal inspector visits.
In-depth internal mock assessments evaluating your risk management, process control, and technical files against ISO standards.
Pathways to QMS Certification
Gap Assessment
QMS Architecture
Mock Inspection
Certification Support
Initial audit evaluating existing operational practices against ISO 13485 clauses and MDR Fifth Schedule requirements.
Drafting standard operating procedures, quality manuals, device master files, and risk management documentation.
Rigorous simulated audits for CDSCO and ISO standards to test personnel readiness and system compliance.
On-site liaisoning during final Notified Body audits and swift execution of CAPA responses.
CDSCO & MDR 2017 Expertise
Navigating medical device compliance in India requires absolute alignment with the Fifth Schedule of Medical Device Rules 2017. Our veteran auditors bring practical insight into CDSCO inspector expectations, ensuring your quality management system is fully defensible during regulatory reviews.
From selecting the right accredited Notified Body to managing post-audit findings, Artexa serves as your dedicated compliance partner every step of the way.
Connect with Artexa regulatory specialists to schedule your QMS gap assessment or mock audit.