Tech Documentation
Comprehensive, Compliant, and Market-Ready Documentation
At MedQCompliance, we help medical device manufacturers build complete, audit-ready Technical Documentation — a crucial foundation for regulatory approvals and quality management system (QMS) compliance.
What is Technical Documentation?
Technical Documentation (or Technical File/Design Dossier) captures the entire lifecycle of a medical device — from initial design and development to final verification, validation, and risk assessment. It serves as formal evidence that a device is safe, effective and meets regulatory requirements in global markets, including the EU (MDR/IVDR), US (FDA 510(k), PMA), ASEAN, and others.
Why is it Critical?
Clear, well-organized Technical Documentation is essential for:
Regulatory Submissions
It demonstrates conformity with essential requirements and regulatory standards.
QMS Compliance
Supports ISO 13485 and 21 CFR Part 820 requirements for design control and risk management.
Audit Readiness
Facilitates successful Notified Body audits, FDA inspections, and other regulatory reviews.
Market Access
Speeds up approval processes and reduces the risk of delays or rejections.
Our Technical Documentation Services Include
- Design and Development Planning
- Design Inputs and Outputs Documentation
- Risk Management (ISO 14971 Compliance)
- Verification and Validation Evidence
- Clinical Evaluation Reports (CERs) and Clinical Data Summaries
- Labeling and IFU Documentation
- Manufacturing Process Descriptions
- Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) Planning
- Regulatory Strategy and Submission Readiness
Partner with MedQCompliance
To build strong, compliant technical documents that help bring your medical device to global markets faster and with confidence.
Frequently Asked Questions
Get quick answers to common questions about MedQ Compliance’s services and Medtech regulatory consulting.
You can connect with us through our website, LinkedIn, Google search, or referrals to schedule an initial consultation.
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.