RegPro Medical Ltd. consulting@regpromedical.com +1 (800) 513-3110
Our Services
We have supervised and directed all aspects of compliance for
product portfolios of over 3500 medical devices
into over 90 countries worldwide
Post-Market Surveillance & Vigilance (Deep Expertise)
Post-market surveillance is a central focus of our regulatory practice.
- PMS Compliance Gap Assessment.
- MDR & IVDR-compliant PMS plans, PMS reports, & PSURs.
- PMCF documentation.
- PMS SOP development & lifecycle maintenance.
- Building compliant processes for vigilance, FSCA, and trend reporting.
- PMS scalability for growing product portfolios.
- Managing communications with NB, Competent Authorities, and EU REP.
​- Maintaining clear linkage between PMS outputs, risk management, and clinical evaluation.
- Documenting ongoing benefit–risk acceptability.
Regulatory Strategy & Technical Documentation
We provide regulatory strategy development and technical documentation support aligned with EU MDR and IVDR requirements.
-Preparation, remediation, and maintenance of technical files.
- Maintaining design documentation, clinical evaluation, risk management, and post-market surveillance that are complete, internally consistent, and defensible throughout the product lifecycle.
-Designing compliant labelling and instructions for use.
-Creating practical, Notified Body-friendly documentation.
Responses & Recovery
We bring you the expertise you need to respond quickly and thoroughly to audit & inspection findings to keep your device on the market and keep your QMS effective.
- Coordinating Audit & Inspection Response.
- Orchestrating Corrective Actions Follow-Through.
- Preparation for and Response to FDA Inspection.
- Managing Warning Letter Response Strategy.
- Supplier Auditing and corrective actions.
- Internal Auditing and Gap Assessment.
Start Ups
From your initial device design concept through initial launch, we will support your goals to build and scale up your QMS and initial marketing clearances
- QMS Design & Launch.
- Establishing and Guiding Design Controls.
- Coordinating Verification & Validation.
- Thorough Integration of Risk Management.
- Developing Regulatory Strategy.
- Establishing ISO 13485 Compliance.
- FDA registration, listing, & clearance.
- Health Canada Licensing.
- CE Marking.
Growth & Expansion
When you're ready to expand to new markets, we will be there to help you clear the regulatory hurdles
- CE Marking.
- MDSAP Certification.
- FDA -USA registration, listing, and clearance.
- Health Canada Licensing.
- Coordinating ISO 13485 Certification.
- Regulatory Strategy Development & Enhancement.
- Technical Files Creation.
- Roadblock Busters.
QMS Enhancement
If you have a mature, established quality management system, we will guide your team to drive innovation, customer satisfaction, continuous improvement, and profitability.
- Enhancing Top Executive Control and Oversight.
- Management Review best practices.
- CAPA & Nonconformance Management.
- Internal Auditing.
- Quality System Assessment & Remediation.
- Process Development & Optimization.
- Change Control & Configuration Management.
- Design & Risk Management Integration.
- Supplier Quality Management.
- Post-Market Processes Enhancement.
We're Here To Help
What is One Question we can answer for you today?