QMS Implementation and Certification
What's included in
QMS Implementation and Certification
We assist clients in achieving compliance with critical quality standards such as ISO 13485 and 21 CFR Part 820 by handholding, training of resources at client’s end and obtain ISO 13485 certification from global notified bodies. Our in-depth knowledge of these standards ensures that your products meet the highest quality benchmarks.
Assessment and Planning
Begin with a comprehensive assessment of your current processes. Plan tailored Quality Management System (QMS) implementation aligned with ISO 13485 and 21 CFR Part 820.
Documentation Development
Create detailed documentation of processes and procedures. Ensure alignment with quality standards, fostering a culture of compliance and continuous improvement.
Training and Implementation
Conduct thorough staff training on QMS processes. Implement the QMS across the organization, embedding quality practices into daily operations.
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Unlock regulatory mastery, ensure quality compliance, and expedite market entry. Elevate your MedTech success story with our tailored solutions and expert guidance.
Frequently Asked
Get quick answers to common questions about MedQ Compliance’s services and Medtech regulatory consulting.
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MedQ Compliance specializes in preparing a tailored regulatory strategy for your medical device solution, support in building technical documentation and completing regulatory submissions in global markets such as US FDA, EU MDR/ IVDR, CDSCO India, Singapore HSA, and other countries.
MedQ Compliance prioritizes confidentiality, implementing secure processes for information protection.
Timelines for regulatory approvals depend on multiple factors such as completeness of the technical dossier, meeting applicable requirements and timely communication with the regulatory bodies. MedQ Compliance optimizes all these key areas that ensure high efficiency and minimal timelines for regulatory clearances.