Empowering Your MDR Approval Journey
Our Vision and beliefs is that a Quality Management system should be the backbone of a company and not a burden to carry.
Our mission is to empower our costumers to reach their MDR approval journey safely and cost effective, dedicating their time and energy to build products safely and with highest Quality
About the Founder
Adel Greb - Founder and CEO, ReguPartner
With over 15 years of experience in MedTech and software industries, I help startups, scale-ups, and established companies navigate complex regulatory challenges and bring innovative products safely to market.
Before founding ReguPartner, I was Chief Quality & Regulatory Officer and PRRC at FRISQ AB, and later Quality & Regulatory Affairs Manager at Cambio Group. I successfully led MDR transitions, built ISO 13485-compliant QMS from the ground up, and guided CE-marking processes for digital health software across Europe.
My expertise covers ISO 13485, ISO 14971, ISO 27001, FDA, GDPR, HIPAA, IEC 62304, and emerging AI regulations (ISO 42001). At ReguPartner, I bring this hands-on experience and a pragmatic approach to help MedTech companies stay compliant, agile, and innovation-focused.
Why I Started ReguPartner
After years of working in-house, I saw how many companies struggle to balance compliance with agility. ReguPartner was born to make regulatory support simpler, faster, and more effective — tailored for the realities of modern MedTech development.
Adel Greb
Founder & CEO
Need expert guidance with MDR or QMS?
Let’s talk about how ReguPartner can support your regulatory journey — from idea to approval.
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.
5 Common Pitfalls in MDR Technical Files — and How to Avoid Them
Adel Greb
Navigating the Medical Device Regulation (MDR) can feel overwhelming — especially when it comes to compiling a compliant technical file. After reviewing and submitting dozens of files, I’ve seen the same mistakes pop up time and again.
Avoid these 5 common pitfalls to strengthen your submission and reduce costly delays:
1. Incomplete Risk Management Documentation
Many companies underestimate how deeply MDR ties the technical file to ISO 14971. A standalone risk matrix isn't enough — you need traceability from risk analysis to design controls, verification, and post-market surveillance.
Tip: Align your risk documentation directly with your design and usability work. Consider linking risks to mitigations across the lifecycle.
2. Weak Clinical Evaluation Reports (CER)
Regulators are increasingly focused on clinical evidence. Reused or outdated CERs from the MDD era often fall short of MDR expectations.
Tip: Make sure your clinical data is current, device-specific, and aligned with MEDDEV 2.7/1 Rev 4 and MDCG guidance.
3. Unclear Software Documentation
If your product includes software, lack of structure in IEC 62304 and IEC 82304 documentation is a red flag. This includes missing software architecture, SOUP justifications, or version control plans.
Tip: Organize your software file in line with IEC 62304 clauses, and don't forget the software risk classification justification.
4. Gaps in Post-Market Surveillance Plans
Some companies treat PMS as an afterthought. However, MDR expects a proactive, data-driven approach integrated into your QMS.
Tip: Use real-world use cases and complaint trends to show how PMS feeds into continuous improvement and risk reevaluation.
5. Lack of Documented PRRC Responsibility
The Person Responsible for Regulatory Compliance (PRRC) must be clearly assigned and documented. Not having this role filled, or failing to prove their qualifications, can stop the submission cold.
Tip: Maintain a signed role description and CV for the PRRC as part of your QMS.
Final Thoughts
A strong technical file isn’t about ticking boxes — it’s about telling a coherent, compliant story about your device's safety, quality, and performance.
If you’re unsure whether your technical documentation is ready for MDR, book a call with ReguPartner or contact us at info@regupartner.se — and let’s make your submission smooth, not stressful.