Regulatory Compliance (MDR/FDA)


Navigating the intricate landscape of medical device regulatory compliance is crucial for timely market entry.
MedDev Soft specializes in ensuring that your product aligns with the stringent regulations of the medical device industry, covering MDR, FDA, and other global standards.

Regulatory Compliance Highlights

Regulatory Strategy and Support
Expert guidance in developing and implementing a regulatory strategy tailored to your product, including device classification consultation.

Premarket Processes
Assistance with premarket clearance and approval, ensuring compliance with MDR and FDA regulations.

Compliance Standards and Validation
Adherence to GAMP guidelines and conducting NPS validation to meet regulatory standards..

Quality Assurance and Quality Control
Implementing QA and QC processes in line with QMS ISO 13485 and 21 CFR Part 820, and utilizing integrated software solutions for ALM and QMS.

MedDev Soft is committed to providing comprehensive support for regulatory compliance, ensuring that your medical device meets all necessary standards and regulations for a successful market launch.

Accelerate your path to market with MedDev Soft’s regulatory compliance expertise. Contact us to navigate the complex regulatory landscape with confidence, ensuring your medical device meets all necessary standards and approvals.

Regulatory Compliance in Detail

Regulatory Strategy Development

Crafting and implementing tailored regulatory strategies.

Device Classification Consultation

Assisting in accurate device classification for regulatory pathways.

Premarket Clearance and Approval Guidance

Navigating premarket processes for market access.

MDR and FDA Compliance

Ensuring adherence to EU and US regulatory standards.

GAMP Compliance Implementation

Following Good Automated Manufacturing Practice guidelines.

Non-Product Software Validation

Validating software used in manufacturing and maintenance.

Quality Assurance Processes

Implementing QA standards and procedures.

Quality Control Measures

Adhering to QC standards for product reliability.

Integrated Software Management

Streamlining compliance with regulatory standards using ALM and QMS solutions.

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