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).
- 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 processes 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 Writing – FDA 510(k), PMA, De Novo applications, and EU Technical Files.
- Safety & Performance Reporting – SSCP, General Safety and Performance Requirements (GSPR).
- Post-Market Surveillance (PMS) & Clinical Follow-Up (PMCF, PSURs) – Ongoing compliance planning, 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 Trends & Updates – Stay ahead of evolving regulations and industry expectations.
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.
What is the difference between FDA 510(k), PMA, and De Novo pathways?
What are the key requirements for CE marking in the EU?
How long does it take to get FDA approval for a medical device?
What is ISO 13485, and why is it important?
Do all medical devices require clinical trials?
What is post-market surveillance (PMS), and why is it necessary?
How can ADRES help with regulatory submissions?
How are medical devices classified under FDA and EU MDR?
What are the main differences between FDA and EU MDR regulatory requirements?
How do I ensure my device meets EU MDR General Safety and Performance Requirements (GSPR)?
What is the role of Notified Bodies in EU MDR compliance?
How can manufacturers ensure continuous compliance with regulatory standards post-certification?
Why Choose ADRES?
When you choose ADRES, you are not just opting for a service; you are selecting a partnership that will provide expert guidance through every stage of your medical device development and regulatory journey. Our team of seasoned professionals will assist in the initial design and development phase, ensuring that your device meets all necessary standards from the ground up.
We will help you compile and update comprehensive technical documentation and navigate the stringent requirements of Notified Bodies. Our dedicated support extends to implementing and maintaining an effective post-market surveillance system, ensuring your device remains compliant long after initial certification.
By choosing ADRES, you gain access to a wealth of knowledge that keeps pace with the evolving regulatory landscape. Our continuous training programs will empower your staff with up-to-date compliance information and best practices, enabling them to uphold the highest standards of quality and safety. With ADRES, you can rest assured that your medical device approval process will be seamless and efficient.
