Ensure your medical device meets regulatory standards with our expert Clinical Evaluation Reports (CER) services. We provide comprehensive support from data collection to evidence appraisal, helping you achieve compliance efficiently.
The medical device industry plays a critical role in modern healthcare, delivering innovative solutions that enhance patient outcomes, improve diagnostics, and streamline treatment processes. Spanning a wide range of products from simple instruments to complex, technology-driven devices, this industry is at the forefront of medical innovation, combining engineering, biotechnology, and regulatory compliance to meet global health needs.
Navigating regulatory requirements for medical devices can be complex, and CERs play a critical role in demonstrating safety and performance in compliance with international standards such as the EU Medical Device Regulation (MDR 2017/745) and other global frameworks. A well-prepared CER not only supports regulatory submissions but also ensures that medical devices consistently meet the highest standards of clinical safety and effectiveness.
Post-market surveillance (PMS) further strengthens this process by monitoring the performance and safety of medical devices once they are on the market, focusing not only on quality assurance but also on regulatory compliance and timely reporting to local authorities. This proactive vigilance ensures cooperation with national authorities, enhances patient safety, and drives continuous improvement in medical device performance, ultimately safeguarding public health while supporting market sustainability.
We provide end-to-end support for medical device companies, helping them navigate the entire product lifecycle, from research and development to market access and PMS. Our services are designed to ensure compliance, efficiency, and safety, keeping patient welfare at the center of every solution.
Support for global regulatory compliance, including FDA, CE marking, and other regional approvals.
Guidance on ISO 14971-based risk assessments, incident reporting, and corrective actions.
Professional scientific writing, clinical study reports, and regulatory documentation for devices ranging from Class I to Class III.
Comprehensive preparation and maintenance of CERs to demonstrate safety and performance in line with MDR and ISO 13485 requirements.
Collection, analysis, and reporting of post-market data to ensure ongoing device safety and compliance.
End-to-end support in preparing high-quality technical files and design dossiers.
Comprehensive preparation and maintenance of CERs to demonstrate safety and performance in line with MDR and ISO 13485 requirements.
Support for global regulatory compliance, including FDA, CE marking, and other regional approvals.
Collection, analysis, and reporting of post-market data to ensure ongoing device safety and compliance.
Guidance on ISO 14971-based risk assessments, incident reporting, and corrective actions.
End-to-end support in preparing high-quality technical files and design dossiers.
Professional scientific writing, clinical study reports, and regulatory documentation for devices ranging from Class I to Class III.
At Pubrica, we provide specialized support across a wide range of medical device segments, helping manufacturers navigate regulatory compliance, clinical evaluation, and post-market requirements with precision and efficiency. Our expertise spans multiple device categories, ensuring tailored solutions for every stage of your product lifecycle. Key Segments Include:
MRI, CT, ultrasound systems, X-ray machines, and laboratory diagnostic equipment.
Surgical instruments, infusion pumps, dialysis equipment, and physiotherapy devices.
Wearable devices, patient monitors, and remote monitoring systems.
Orthopaedic implants, cardiovascular devices, dental implants, and prosthetic limbs.
Mobile health applications, AI-based diagnostic tools, and software-as-a-medical-device (SaMD).
Surgical instruments, operating room equipment, anaesthesia machines, and infusion pumps.
CER for medical devices is typically categorized based on the risk class of the medical device under regulations such as the MDR 2017/745 or other regional frameworks. The classes reflect the potential risk a device poses to patients. Here's a detailed breakdown:
| Class | Description | Examples | CER Focus |
|---|---|---|---|
| Class I Devices (Low Risk) | Non-invasive devices or those with minimal risk to the user. | Bandages, stethoscopes, examination gloves. | • Clinical evaluation is often based mainly on literature review and well-documented experience. • Clinical data requirements are generally less stringent than those for higher-risk classes. |
| Class IIa Devices (Medium-Low Risk) | Moderately invasive or pose moderate risk. | Dental fillings, infusion pumps, ultrasound equipment. | • Requires more detailed clinical data than Class I. • May include post-market clinical follow-up (PMCF) or limited clinical investigations. |
| Class IIb Devices (Medium-High Risk) | Invasive or significant impact on patient health if they fail. | Ventilators, anaesthesia equipment,and implantable devices like pacemakers (non-life-sustaining). | • CER must rely on robust clinical evidence. • Usually requires clinical investigations or well-controlled studies in addition to the literature. |
| Class III Devices (High Risk) | Devices that are life-sustaining or life-supporting, or have a high risk of serious health consequences. | Heart valves, implantable defibrillators, some orthopaedic implants. | • Requires extensive clinical data from trials and real-world evidence. • CER is a critical component for regulatory approval and must demonstrate safety, performance, and clinical benefit comprehensively. |
PMS is important to ensure the safety, efficacy, and performance of medical devices after they are released to the market and used by the public.
Identifies unforeseen risks and device failures that enable fast mitigation of life-threatening or long-term injuries with the aid of a PMS strategy.
Collects real-world performance data to uncover risks and limitations not evident in clinical trials.
Aligns with EU MDR and US FDA requirements to ensure device safety, quality, and performance across its lifecycle.
PMS guidelines for the medical industry include references such as the Medical Device Guidance Documents (MEDDEV) and the Medical Device Coordination Group (MDCG) guidelines in the EU.
PMS guidelines from different organizations are listed below.
Our authors share Pubrica's expert content in top-tier journals, conferences, and platforms, maximizing and amplifying its recognition and reach. Our placement will enhance our visibility and elevate our standing in an authoritative capacity.
Paper Title: Novel Approaches to Combat Medical Device-Associated Biofilms
Author: Xin Li, Luyao Sun, Peng Zhang, and Yang Wang
Journal Name: Coatings
Publisher: MDPI
Impact factor: 2.8
Pubrica's team of industry specialists offers unrivalled expertise and perspectives to provide complete solutions with precision and originality. Through a mix of both experience and specialization, they strive for excellence in everything they do.
PHD, FIAMS, DMRD, DMRE, DNB - Medical
MD - Medical
MD - Medical
Pubrica's expertise in Clinical Evaluation Reports helped us meet stringent EU MDR requirements without delays. Their team provided in-depth literature reviews, well-structured analysis, and clear documentation that impressed both our internal auditors and regulators.
— Dr. Anna Müller
Regulatory Affairs Manager,
Germany
The CER prepared by Pubrica was comprehensive, evidence-based, and aligned with the latest regulatory expectations. Their subject matter experts ensured our Class II device submission sailed through smoothly.
— James Carter
Director of Quality & Compliance,
United Kingdom
We were struggling with MDR compliance for our clinical evaluation. Pubrica's team stepped in with outstanding guidance, timely delivery, and high-quality CER documentation. Their support gave us confidence in facing notified bodies.
— Dr. Marc Dubois
Clinical & Regulatory Consultant,
France
Journals expect a clear structure for case reports and review articles, featuring precise objectives, rigorous timeline analysis..
Publishing a case report involves more than clinical knowledge; it also demands strategic journal targeting, matching visibility metrics..
Effective patient education materials (PEMs) are crucial for promoting health literacy, enhancing compliance, and bridging care delivery gaps..