“We guide you through a structured and efficient path to achieve MDR approval and maintain a strong Quality Management System.”
Initial Assessment & Gap Analysis
We evaluate your current system to identify areas for improvement.
QMS Development & Documentation
We help build or refine your Quality Management System aligned with MDR and ISO 13485.
Technical File Preparation & Submission
We prepare and submit comprehensive technical documentation to the Notified Body.
Audit Support & PRRC Services
We provide expert guidance during audits and act as your Person Responsible for Regulatory Compliance.
Continuous Compliance & Improvement
We support ongoing compliance with evolving regulations to keep your products safe and market-ready.
🔹 Startup MDR Package
Quick-start compliance for new MedTech products.
Includes MDR gap analysis, essential QMS setup, and technical file preparation.
🔹 Full QMS Build
End-to-end Quality Management System implementation.
We design, document, and implement a fully compliant QMS based on ISO 13485 and MDR.
🔹 PRRC Retainer Service
Ongoing compliance leadership from a certified expert.
We act as your Person Responsible for Regulatory Compliance (PRRC), ensuring continuous oversight.
🔹 Audit & Compliance Review Package
Independent audits with actionable results.
We assess your QMS, technical documentation, and readiness for internal or external audits.
🔹 Training & Support Program
Upskill your team on regulatory frameworks.
Custom workshops and hands-on support covering MDR, ISO 13485, risk management, and more.
Your business may have unique needs—we’re ready to create a custom service plan to fit your product, your timeline, and your goals.
From QMS design to full MDR compliance, we deliver tailored regulatory and quality solutions that help you innovate safely, scale confidently, and meet every milestone.
Support at the executive level to align product, business, and regulatory priorities.
Provide interim or part-time QA/RA leadership
Align regulatory, business, and product priorities
Guide strategic decisions with compliance in mind
We build efficient, ISO 13485-compliant QMS structures that scale with you.
Design and implement ISO 13485-compliant QMS
Deliver complete documentation and SOPs
Support audits and continuous improvement
Navigate EU MDR, IVDR, AI regulations, and international requirements with confidence.
Prepare and review MDR/IVDR technical files
Manage CE-marking and Notified Body submissions
Ensure compliance with ISO 14971, 27001, 62304
Upskill your team with practical, tailored regulatory and quality training.
Deliver tailored internal QA/RA training
Support onboarding for regulatory and quality roles
Upskill teams in MDR, QMS, and risk management
Keep projects moving efficiently while staying compliant.
Lead regulatory and quality projects
Implement structured change control processes
Ensure timelines align with compliance goals
Prepare for and respond to audits with confidence.
Perform internal and supplier audits
Prepare for Notified Body inspections
Address CAPAs and resolve deviations
Official EU MDR-compliant PRRC services tailored to your needs.
Act as your EU MDR-compliant PRRC
Define and implement PRRC processes
Interface with authorities and Notified Bodies
Ensure regulatory compliance is embedded in your product from day one.
Provide guidance through the full product lifecycle
Apply IEC 62304 and 62366-1 during development
Ensure early alignment with regulatory strategy
Enhance product quality and development efficiency with proven QA strategies.
Plan and execute V&V for MedTech software
Integrate risk-based testing under Agile or hybrid models
Align QA with ISO 13485, IEC 62304, and MDR
