Comprehensive Regulatory Guidance
for Medical Devices

Navigating medical device regulations requires a partner with comprehensive expertise, not just in compliance but in supporting the entire lifecycle of your product. Nerac’s medical device team offers a wide range of research, regulatory, and subject matter expertise, with a focus on clinical evidence through rigorous literature search and review. We aim to be your trusted partner, guiding you through every step of regulatory compliance.

5,000+

Users Worldwide

23,000+

Research Reports

57+

Years in Business

Why Nerac?

Nerac’s medical device analysts are trained, experienced, and competent in clinical literature search, research methodology, information retrieval, clinical research ethics, and medical and scientific literature analysis. We leverage this knowledge to help you navigate complex regulatory requirements, ensuring compliance with a range of international standards and guidelines.

Our Services

At Nerac, we specialize in the following areas to ensure your medical devices meet the highest regulatory standards:

Clinical Literature Reviews and Evaluations

Our analysts perform thorough literature searches and evaluations to support various regulatory submissions, including those for the EU MDR/IVDR, US FDA, China NMPA, and Health Canada. These reviews are crucial in providing clinical evidence for the regulatory approval process.

Regulatory Submission Support

We guide you through the complex process of regulatory submissions, whether it’s for FDA clearances, CE marking, or other international approvals. Our experienced team ensures all documents are accurate and meet the requirements of the relevant regulatory bodies.

Medical Device Regulations

Quality Management System (QMS) Development

We assist in establishing and maintaining ISO 13485-compliant quality management systems. Our support helps you create robust processes to ensure continuous compliance and readiness for regulatory audits.

Post-Market Surveillance

Compliance doesn’t end with product approval. We provide ongoing support for periodic literature surveillance and adverse event monitoring, ensuring the safety and effectiveness of your medical devices throughout their lifecycle.

Post Market Surveillance

Industry Expertise

Nerac analysts have extensive experience in various medical device and therapeutic areas, including but not limited to:

  • Gastrointestinal Surgery

  • Electrosurgical Devices

  • Wound Care

  • Cardiology

  • Ophthalmology

  • Dentistry

  • Medical Imaging

  • Medical monitoring

  • Orthopedics

  • Gynecology

  • Urology

  • General and Endosurgery

  • Renal

  • Respiratory

  • Interventional Radiology

  • Active Implant

  • In-Vitro Diagnostic Devices

  • Advanced Materials

This wide-ranging expertise allows us to provide tailored support across different product categories and regulatory landscapes.

The Nerac Difference

Nerac’s services allow clients to quickly expand their in-house research operations with exceptional expertise and scalable capability. Unlike many consulting firms that focus on large projects, Nerac specializes in providing rapid response research and advisory services for mission-critical engagements. Our team of expert advisors offers personalized solutions and insights that help you make better, faster business decisions.

Benefits of a Nerac Subscription

A Nerac subscription offers numerous benefits for clients who require frequent regulatory support:

Convenience and Scalability

Easily scale your research operations with on-demand access to expert analysts.

Cost Savings and Predictability

With a subscription, you gain cost-effective services and better financial forecasting.

Direct Communication and Collaboration

Enjoy a direct line of communication with our experts, fostering stronger business relationships.

Higher Customer Engagement

Our collaborative approach ensures your needs are met with personalized services and tailored support.

Meet Our Medical Device Analysts!

Our medical device analysts bring a wealth of experience and are dedicated to providing you with the best regulatory support:

Erica Kramer, Ph.D.

Priscilla S. Monarca, M.P.H.

Miriam Sharif-Murray, M.S.

Contact Us Today

Interested in learning how Nerac can help with your medical device regulatory needs? Contact us to discuss your specific requirements and discover how our team can guide you through the complex regulatory landscape. We’re here to help you achieve compliance and ensure the success of your medical devices.

Medical Device Regulatory Services FAQs

Nerac emphasizes ensuring regulatory compliance for medical devices, focusing particularly on the crucial aspect of clinical evidence. Our services involve comprehensive literature searches and reviews, which are fundamental in navigating the complex regulatory requirements and supporting the clinical evaluation process for medical devices.
The analysts at Nerac are specialized in the nuanced field of medical device regulation, equipped with expertise in clinical literature search, research methodologies, and ethics. They are adept at conducting analyses according to internationally recognized guidelines, ensuring the clinical evidence underpinning medical devices meets rigorous regulatory standards.
In response to the stringent EU Medical Device Regulation (MDR)/EU In Vitro Diagnostic Regulation (IVDR), Nerac offers targeted support through detailed clinical literature reviews and evaluations. This service is specifically designed to meet the demands of the EU MDR/IVDR based on their experience successfully authoring NB audited documents, providing essential documentation and insights to facilitate compliance and market access in the European Union.
Beyond the EU, Nerac extends its regulatory support to include submissions in other key markets such as the United States, China and Canada. Our expertise encompasses literature reviews and regulatory submission support tailored to the requirements of the US Food and Drug Administration (FDA), The National Medical Products Administration (NMPA), the Chinese agency for regulating drugs and medical devices and Health Canada, assisting in navigating the regulatory pathways across different jurisdictions.
Recognizing the importance of ongoing surveillance post-market launch, Nerac offers services for periodic literature surveillance. This is crucial for maintaining compliance with regulatory requirements, monitoring the safety and efficacy of medical devices throughout their lifecycle, and ensuring any potential safety issues or adverse events are promptly addressed.
What sets Nerac apart in the domain of medical device regulatory services is their comprehensive approach, combining in-depth research expertise with a keen understanding of regulatory frameworks. This enables them to provide nuanced support that encompasses not just compliance but strategic insights for navigating the global regulatory landscape effectively.

Our Medical Device Regulatory Articles

Get Our Newsletter

Sign up for The Nerac Strategist to keep up to date with the latest Nerac content.

Select Your Area(s) of Interest *