Medical Devices – Technical Documentation
Comprehensive Regulatory Support for Compliance and Market Approval
Ensuring proper technical documentation is a fundamental requirement for bringing medical devices to market and maintaining regulatory compliance. At CRONET, we provide end-to-end support in the preparation, management, and maintenance of technical files, aligning with global regulatory frameworks such as MDR (EU) 2017/745, ISO 14971, and FDA requirements.
Our team specializes in structuring documentation that meets the highest standards, ensuring seamless regulatory approvals, risk management, and post-market compliance. Whether you are preparing for CE marking, FDA submission, or ongoing compliance activities, we provide tailored solutions for your needs.
Technical File Preparation
We assist in the creation and organization of comprehensive technical files, including:
All documentation is prepared in accordance with MDR (EU) 2017/745 and other relevant regulations, ensuring a smooth approval process.
Design Dossier Development
For Class III and implantable devices, we develop detailed design dossiers, including:
These dossiers support regulatory submissions and demonstrate compliance with rigorous safety and efficacy standards.
Risk Management Documentation
In compliance with ISO 14971, we create structured risk management files that:
This ensures that all risk-related aspects are thoroughly evaluated, recorded, and aligned with regulatory expectations.
Post-Market Surveillance Documentation
Medical device compliance doesn’t stop at market entry. We assist in preparing:
These documents help manufacturers maintain ongoing regulatory compliance and respond proactively to safety concerns.
Regulatory Compliance & Conformity Assessment
We support manufacturers in compiling the necessary documentation to demonstrate conformity with international regulatory requirements, including:
Our expertise ensures a structured and compliant submission process, reducing delays and regulatory challenges.
Why Choose CRONET?
Expertise in Global Regulations
Deep understanding of MDR, ISO 14971, FDA and other standards.
End-to-End Support
From initial technical documentation to post-market compliance.
Tailored Strategies
Custom solutions based on device classification and market requirements.
Regulatory Success
Helping companies achieve smooth approvals and maintain compliance.