Regulatory Services
Simbex is a leading regulatory consulting firm specializing in medical device regulations. Our team of experts is dedicated to helping you navigate the complex landscapes of both U.S. FDA and EU regulations.
Our Regulatory Approach
Planning your medical device regulatory strategy from the outset can significantly streamline the product development process. Early consideration of regulatory requirements can help avoid costly and time-consuming revisions to ensure a successful journey to market for your medical device.
U.S. FDA Regulations
Our consultants are experienced in the intricacies of FDA regulations for medical devices. We can assist with premarket submissions, quality management system regulation (QMSR) compliance, and more.
- Premarket Approval Assistance: We ensure your device meets FDA’s scientific and regulatory requirements for clearance or approval.
- Quality System Regulation Guidance: We help you establish a compliant quality system as per FDA’s QSR.
- Regulatory Training: We provide training on FDA regulations to ensure your team is informed and effective.
EU Regulations
We have extensive experience with EU’s Medical Device Regulation (MDR 2017/745). Our team can guide you through the process of obtaining your CE mark and ensure your product meets all necessary requirements.
- CE Mark Guidance: We walk you through the CE marking process, ensuring your device meets EU’s MDR requirements.
- Technical Documentation Review: We review your technical documentation for compliance with EU MDR 2017/745 Annex II.
- Post-Market Surveillance Assistance: We support setting up a compliant post-market surveillance system as per EU MDR 2017/745 Articles 83 to 86 and Annex III.
Our Regulatory Services
Regulatory Strategy Development
We drive the development of a regulatory strategy that aligns with your business goals and ensures compliance with relevant regulations.
- Regulatory Pathway Determination: We collaborate with you to identify the most efficient regulatory pathway for your device.
- Risk Management: We assist in identifying and mitigating regulatory risks.
- Regulatory Intelligence: We provide insights into regulatory changes and trends.
Submission Preparation and Review
Our team works with your team to prepare and review regulatory submissions to ensure they meet all necessary requirements.
- Document Preparation: We aid in the preparation of necessary documents for regulatory submissions.
- Submission Review: We review your submissions for completeness and accuracy.
- Response to Regulatory Queries: We support in cultivating responses to any queries from regulatory authorities.
Quality System Compliance
We navigate you through the steps on establishing and maintaining a quality system that complies with FDA QMSR and EU’s ISO 13485.
- Quality System Setup: We steer you in setting up a compliant quality system.
- Quality System Review: We conduct reviews to ensure your quality system remains compliant.
- Quality System Training: We provide training to ensure your team understands and maintains the quality system.
Post-Market Surveillance
We assist in setting up post-market surveillance systems to monitor the safety and performance of your medical devices.
- Surveillance System Setup: We lead you through the process of setting up a compliant post-market surveillance system.
- Safety Monitoring: We help monitor the safety and performance of your devices post-market.
- Incident Reporting Guidance: We guide you on incident reporting as per regulatory requirements.
US Agent
We offer comprehensive FDA US Agent services for OUS medical device manufacturers, acting as a liaison between the FDA and foreign establishments.
- FDA Registration: We support and manage your FDA registration and product listing.
- FDA Inspection: We give instruction on navigating FDA inspections and handle any regulatory issues that may arise.
Person Responsible for Regulatory Compliance
We deliver thorough PRRC services for micro- and small-businesses seeking compliance with EU MDR 2017/745 Article 15.
- Regulatory Guidance: Provides counsel on the interpretation and application of EU MDR 2017/745 regulations, ensuring that medical devices comply with the necessary standards.
- Documentation Review: Reviews and approves technical documentation, ensuring it meets the requirements of EU MDR 2017/745 for medical device certification.
- Risk Management: Oversees risk management activities, including the identification, evaluation, and control of potential risks associated with medical devices as per EU MDR 2017/745 guidelines.
Key Challenges We Solve
Our team of regulatory experts addresses several key challenges:
Navigating Complex Regulations
We help clients understand and navigate the complex landscape of medical device regulations in various jurisdictions, including the U.S. FDA and EU MDR.
Ensuring Compliance
We assist clients in establishing and maintaining quality systems that comply with regulatory requirements, thereby reducing the risk of non-compliance penalties and product recalls.
Facilitating Market Access
By guiding clients through the regulatory submission process and helping them respond to regulatory queries, we facilitate quicker market access for their medical devices.
Get Started with a Regulatory Strategy Report
Your journey to compliance starts here.
A Regulatory Strategy report from Simbex will outline key information you need to make informed and strategic decisions based on the regulatory requirements for your target market.
Sections include:
- Intended Use Statement (We’ll help you develop it if you don’t already have one)
- Device classification
- Predicate Device Analysis (US only)
- Applicable industry standards and testing requirements
- An outline of documentation required for regulatory submission
- Overview of Quality System Requirements
- Anticipated timeline and cost for regulatory milestones for target market
