Medical Device Regulatory and Quality Services

Navigate Medical Device Regulations with Confidence

At ADRES, we provide comprehensive regulatory and quality assurance support for medical device companies, helping them achieve compliance with FDA, EU MDR, and other global regulatory frameworks. Our experts guide you through every stage of the regulatory process, ensuring a seamless pathway from product development to market approval.

Our Services

1. Regulatory Compliance

Our regulatory specialists help you navigate complex medical device regulations, ensuring your products meet all necessary requirements for global market entry.

  • FDA and EU MDR Compliance – Guidance on FDA, EU MDR, and international regulatory frameworks.
  • Pre-Market Submissions – Support for FDA 510(k), PMA, De Novo, and CE marking applications.
  • Regulatory Strategy & Pre-Submission Support – Request for Designation (RFD), FDA Pre-Submissions, and discussions with Notified Bodies (NBs).
  • ISO 13485 Consulting – Implementation and certification guidance for global QMS compliance.
  • Risk Management – Ensuring ISO 14971 compliance with structured risk management processes.

2. Quality Management Systems (QMS)

Develop a robust and compliant QMS that aligns with regulatory expectations and enhances operational efficiency.

  • QMS Design & Implementation – Tailored systems to meet ISO 13485, FDA QSR, and MDR standards.
  • CAPA Implementation & Root Cause Analysis – Proactive quality control to address compliance gaps.
  • Internal and Third-Party Audits – Ensure supplier and internal compliance readiness.

3. Product Development & Risk Management

Enhance product safety, performance, and regulatory approval success with structured risk management and usability evaluations.

  • Usability Engineering & IEC 62366 Compliance – Human factors consulting for safer, user-friendly devices.
  • Risk Analysis (FMEA) & Design Controls – Comprehensive assessment to mitigate potential failures.
  • Design Documentation & Compliance Readiness – Preparation of Design History Files (DHF), gap analysis, and regulatory submissions.
  • Biocompatibility Planning & Reporting – Strategic support in biological evaluation planning and execution.

4. Regulatory & Technical Writing Services

Our expert regulatory writers ensure clear, compliant, and high-quality documentation for both FDA and EU MDR submissions.

  • Regulatory Submissions – FDA 510(k), PMA, De Novo applications, and EU Technical Files.
  • Safety & Performance Reporting – SSCP, General Safety and Performance Requirements (GSPR), and Biocompatibility Evaluations.
  • Post-Market Surveillance (PMS) & Clinical Follow-Up (PMCF, PSURs) – Ongoing compliance monitoring and reporting.
  • Risk Management & Design Documentation – Development of risk management plans, design inputs/outputs, and traceability matrices.
  • Clinical & Scientific Writing – Literature reviews, clinical study protocols, investigator brochures, and informed consent forms.
  • Standard Operating Procedures (SOPs) & Quality Manuals – Ensure operational consistency and compliance readiness.

5. Training & Workshops

We offer customized training programs to keep your team updated on regulatory requirements and best practices.

  • Regulatory & QMS Training – Hands-on workshops covering FDA, MDR, and ISO standards.
  • Data Integrity & Documentation Best Practices – Ensure accuracy and compliance in medical device records.
  • Regulatory Trends & Updates – Stay ahead of evolving regulations and industry expectations.

1. What is the difference between FDA 510(k), PMA, and De Novo pathways?

2. What are the key requirements for CE marking in the EU?

3. How long does it take to get FDA approval for a medical device?

4. What is ISO 13485, and why is it important?

5. Do all medical devices require clinical trials?

6. What is post-market surveillance (PMS), and why is it necessary?

7. How can ADRES help with regulatory submissions?

8. How are medical devices classified under FDA and EU MDR?

9. What are the main differences between FDA and EU MDR regulatory requirements?

10. How do I ensure my device meets EU MDR General Safety and Performance Requirements (GSPR)?

11. What is the role of Notified Bodies in EU MDR compliance?

12. What happens if my medical device is not compliant with regulatory standards?

Why Choose ADRES?

With extensive experience in the medical device industry, ADRES delivers tailored regulatory and quality solutions that streamline compliance, reduce risks, and accelerate market entry. Our expertise ensures that your medical devices meet the highest safety and performance standards worldwide.

Get Started Today

Let us help you navigate the complexities of medical device regulations. Contact us to discuss your compliance needs and develop a strategic approach for your medical device approvals.

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