Leadership at the Executive Level
We offer executive services including CEO and CTO advisory, R&D strategy, financial oversight, M&A support, and vendor management.
Empowering Your MDR Approval Journey
ReguPartner, specializes in Quality and Compliance for software as medical device products. We believe in making Quality Management Systems a company's backbone, not a burden.
Our Unique Services
Explore our tailored services designed for software as a medical device compliance.
Quality Management Systems
Establish and maintain effective Quality Management Systems tailored to your needs.
Regulatory Consulting
Expert guidance through the complexities of MDR approval processes and compliance.
Training and Support
Comprehensive training programs to empower your teams on compliance best practices.
Project Management
End to end project planning in aligned with MDR timeline and requirements, Regulatory strategy development tailored to your software classification, Coordination with Notify Body and other stakeholders
Audit and Compliance Reviews
Thorough internal audits to ensure ongoing compliance and system effectiveness.
Personal Responsible for Regulatory Compliance (PRRC)
Ensuring conformity of devices before release, Oversight of Technical Documentation and QMS, Monitoring post-market surveillance (PMS) and vigilance, Acting as your named PRRC in communication with authorities, Supporting you during audits and regulatory reviews
Product Development
ISO 62304 development,
Patient & FMEA Risk Management, significant & substantial change, eIFU/IFU creation for SaMD,
Ensuring QA with V & V.
New: AI-Powered Compliance Gap Detection
How it Works
Analyzes QMS documents , technical files, and SOPs Detects gaps in MDR, ISO 13485, and other standards Recommends corrective actions with regulatory references Provides real-time monitoring and audit-ready reports
Why It Matters
Why Choose ReguPartner?
Delivering compliant, high-quality software solutions for medical devices.
Expertise in Quality & Compliance
Specialized knowledge in Software as Medical Device Regulations ensures your success.
Streamlined Agile Processes
We simplify quality management and tailor it for software companies needs, saving you time and resources.
Empowerment & Support
We guide you safely through MDR approval and maintaining the certification, focusing on your growth.
Contact Us
Reach out to us for Quality and Compliance support.
Frequently Asked Questions
Key insights to help you navigate quality and compliance in medical software.
What is Regulatory Partner's main focus?
We specialize in Quality and Compliance for software as a medical device products, assisting companies on their MDR approval journey.
How can you help with my MDR approval?
Our mission is to empower customers to achieve MDR approval safely and cost-effectively while ensuring compliance through our support.
What is a Quality Management System (QMS)?
A QMS is a structured system that helps organizations manage their quality processes, ensuring products meet regulatory and customer requirements.
Why is a QMS important for my business?
A robust QMS serves as the backbone of your organization, streamlining compliance and enhancing product safety and quality, ultimately leading to better performance.
How do you simplify QMS certification?
We provide guidance and tools to maintain your certification with less effort, allowing you to focus on product development and safety.
What services do you offer?
We offer consulting services for quality management, regulatory compliance, and support throughout the MDR approval process, tailored to your needs.