Comprehensive Regulatory Guidance for Medical Devices

Navigate medical device regulations with a partner focused on clear, evidence-based decisions across your product’s lifecycle, from clinical literature review to defensible benefit-risk conclusions. Our methods align with MDR, MEDDEV 2.7/1 Rev. 4, and PRISMA to deliver submission-ready evidence for notified bodies and regulatory agencies. Each review follows a transparent, reproducible, and audit-ready process.

Why Nerac?

Nerac’s medical device team is trained and experienced in clinical literature search, research methodology, information retrieval, clinical research ethics, and medical and scientific literature analysis. You can expect structured clinical evaluations built around transparent claims evidence matrices and clearly defined clinical endpoints, aligned with emerging ISO 18969 expectations.

Our approach makes benefit risk rationales explicit and traceable, with benchmarks that feed into predefined acceptance criteria and defensible benefit risk conclusions. This gives manufacturers a reproducible framework for demonstrating sufficient clinical evidence to Notified Bodies and regulators, while minimizing unnecessary complexity for your team and supporting compliance with relevant international standards and guidelines.

5000+

Users Worldwide

23,000+

Research Reports

60+

Years in Business

Our Core Services

We specialize in clinical evidence and international regulatory support to meet EU MDR & IVDR, US FDA, United Kingdom ( UK MDR & UKCA), China NMPA, Brazil (ANVISA) and Health Canada standards.

Clinical Literature Reviews & Evaluations

Our analysts conduct thorough literature searches and evaluations to build clinical evidence for regulatory submissions and periodic Clinical Evaluation Plan (CEP) & Clinical Evaluation Report (CER) updates.

Medical Device Regulations

Regulatory Remediation Support

We help you navigate audits by rapidly remediating Clinical Literature Evaluation (CLE) or CER gaps—delivering timely, methodically explained literature search and evaluation updates that directly support your audit responses and strengthen your technical documentation.

Systematic Literature Searches

We deliver regulatory-grade systematic literature searches designed to meet the highest standards of scientific rigor and compliance.

Post Market Surveillance

Post-Market Surveillance

Compliance continues pre & post-approval—we deliver ongoing periodic literature surveillance, adverse event monitoring, and lifecycle safety/performance tracking for medical device PMS, Post Market Clinical Follow Up (PMCF) report and Periodic Safety Update Report (PSUR).

The Nerac Difference

Nerac’s services enable clients to quickly expand their in-house research operation with exceptional expertise and scalable capability. While many consulting and outsourcing firms focus on serving large project customers, Nerac is one of the few firms in the market focused on providing an attractive choice for clients seeking rapid response research and advisory services for mission-critical engagements that require highly experienced expert advisors in a wide variety of disciplines. This wide-ranging expertise allows us to provide tailored support across different product categories and regulatory landscapes.

Nerac analysts bring extensive experience across medical device and therapeutic areas, including but not limited to:

  • Gastrointestinal Surgery
  • Electrosurgical Devices
  • Wound Care
  • Cardiology
  • Ophthalmology
  • Dentistry
  • Software as a Medical Device (SaMD)
  • Medical Imaging
  • Medical monitoring
  • Orthopedics
  • Gynecology
  • Urology
  • General and Endosurgery
  • Remote Patient Monitoring
  • Renal
  • Respiratory
  • Interventional Radiology
  • Active Implant
  • In-Vitro Diagnostic Devices
  • Advanced Materials
  • Surgical Lasers

Nerac’s Subscription Benefits

A Nerac subscription offers numerous benefits for clients who require frequent 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.

Navigate Complex Regulations with Confidence

Nerac delivers the knowledge, support, and expertise to bring your device to market and keep it there.

Talk to a Nerac Advisor
Schedule a Consultation

Meet Our Medical Device Regulatory Services 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.

Jubil Tom
MD, MPH

Miriam Sharif-Murray M.S., RAC

Priscilla S. Monarca
M.P.H.

Frequently Asked Questions

Working with a Nerac analyst means more than just searches. We understand your technology, guide you through findings, and highlight the most relevant insights and leads for your business objectives.

Your Nerac team offers a range of regulatory services to meet your specific needs. This includes Clinical Evaluation Reports compliant with EU MDR and IVDR, as well as Clinical Literature Evaluations tailored to your requirements. We also provide post-market surveillance support and assistance with U.S. FDA regulatory submissions, helping you navigate regulatory requirements efficiently and confidently.

To complete your Clinical Evaluation Report, your Nerac team will need the Clinical Evaluation Plan (CEP), Instructions for Use (IFU) and/or device manuals, technical documentation, risk management documentation, pre-clinical data, and any complaint records. These materials provide the necessary information for analysis, though additional documents may be requested after our initial review to ensure a thorough and compliant report.

No, customer-provided templates can be used if preferred, but Nerac also has in-house templates tailored for many of the services we provide. This ensures consistency, compliance, and efficiency while accommodating your formatting preferences.

Your Nerac team has supported reputable medical device manufacturers and medical societies across a wide range of specialties. This includes- but is not limited to- medical imaging, general surgery, orthopedics, anesthesiology, oncology, urology, wound care, cardiology, dentistry, in-vitro diagnostics, and public health. Nerac’s diverse team is equipped to meet a variety of regulatory and compliance needs across different product types.

Your Nerac team provides customizable Post-Market Surveillance reports designed to meet your specific needs. Reports are delivered in a formatted Excel file and typically include search results, vigilance databases, clinical literature, and other relevant sources. Depending on your preference, the data can be presented in raw form or analyzed to highlight key insights, helping you monitor product performance, compliance, and safety efficiently.

Your Nerac analyst conducts State of the Art Evaluations using a systematic, methodical approach. Keywords are used to build structured search strategies in established literature databases. Results are initially reviewed at the abstract level, and relevant abstracts are then examined in full. Each document is appraised considering the subject device, alternative treatments or therapies, clinical context, and comparable competitor devices. Guidelines from recognized professional societies are incorporated to provide insight into current best practices, ensuring a thorough and accurate evaluation.

Yes. Your Nerac analyst can review clinical literature, regulatory databases, and relevant publications to identify studies related to X. Nerac assesses reported outcomes, potential adverse effects, and evidence supporting use in the applications you specify, providing a clear, concise summary tailored to your needs.

Yes. Monitoring regulatory and legislative activity across the EU, UK, US, and Canada can be a challenging, especially since these processes often move slowly and can involve pre-regulatory or pre-legislative signals. Your Nerac analyst uses proven strategies to legislation and regulations from inception through final implementation. Providing insights on lessons learned, objections, and legal challenges, helping you stay informed and prepared – while noting that we do not provide legal advice.

Yes. Your Nerac analyst can set up a mediated alert to deliver timely government updates on PFAS legislation and regulatory activities. This ensures you stay informed of relevant developments without having to track multiple sources manually.

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