Develop comprehensive, evidence-based Clinical Evaluation Reports (CERs) that demonstrate the safety, clinical performance, and benefit-risk profile of your medical devices. Our regulatory experts help you achieve EU MDR compliance and accelerate market access with confidence.
Prepare scientifically robust, MDR-compliant Clinical Evaluation Reports (CERs) aligned with EU MDR 2017/745 Annex XIV, MEDDEV 2.7/1 Rev.4, and the latest MDCG guidance to support CE certification and successful Notified Body reviews.
Whether you are developing a new medical device, transitioning from MDD to MDR, renewing your CE certification, or updating an existing CER, our multidisciplinary quality, regulatory, and clinical experts deliver evidence-based clinical evaluations that accelerate market access, ensure regulatory compliance, and support a seamless transition from legacy MDD documentation to full EU MDR compliance.
Our Clinical Evaluation Report (CER) services are delivered by a multidisciplinary team of quality, regulatory, and clinical experts with extensive experience supporting medical device manufacturers throughout the product lifecycle. From CER strategy and Clinical Evaluation Plan (CEP) development to literature reviews, clinical data appraisal, CER preparation, remediation, and updates, we help develop scientifically robust, submission-ready documentation aligned with EU MDR 2017/745 and the latest MDCG guidance.
Establish a tailored clinical evaluation strategy based on your device classification, intended purpose, clinical claims, and available evidence to support a compliant and efficient regulatory pathway.
Develop a structured Clinical Evaluation Plan (CEP) that defines the methodology and framework for the clinical evaluation process.
Conduct systematic and comprehensive literature searches using recognized scientific databases to identify relevant clinical evidence supporting your device.
Prepare a comprehensive State-of-the-Art (SOTA) assessment to demonstrate current clinical knowledge, available treatment options, and the device's position within existing medical practice.
Integrate post-market surveillance data into the clinical evaluation to maintain ongoing compliance and support CER updates.
Critically evaluate all available clinical evidence to assess its relevance, quality, and adequacy for demonstrating safety and performance.
Assess whether the demonstrated clinical benefits outweigh the identified residual risks throughout the device lifecycle.
Prepare a scientifically robust, submission-ready Clinical Evaluation Report that complies with EU MDR 2017/745, MEDDEV 2.7/1 Rev.4, and applicable MDCG guidance which supports successful Notified Body review.
Comprehensive regulatory and clinical evaluation support across all medical device classes under EU MDR 2017/745, helping manufacturers achieve CE certification with confidence.
Examples
Manual wheelchairs, examination lights, non-invasive medical devices
Examples
Sterile surgical drapes, sterile dressings, sterile examination gloves
Examples
Clinical thermometers, blood pressure monitors, measuring syringes
Examples
Surgical forceps, scissors, clamps, retractors
Examples
Infusion pumps, suction devices, hearing aids, dental equipment, diagnostic ultrasound systems
Examples
Ventilators, anesthesia workstations, orthopedic implants, dialysis equipment, infusion pumps
Examples
Heart valves, pacemakers, coronary stents, breast implants, implantable neurostimulators
Keep your Clinical Evaluation Report current and compliant throughout the product lifecycle by incorporating new clinical evidence, post-market data, and regulatory changes.
Our support includes:
Annual CER updates & Periodic reviews
Design and product changes
Integration of new clinical evidence
EU MDR renewal support
PMS & PMCF data incorporation
Notified Body observation support
Vigilance updates
PMS, Field Safety Corrective Action (FSCA) integration
Legacy Device CER remediation and modernization for MDR compliance
Initiate the project by understanding your device, defining the scope, and reviewing the available documentation.
Assess existing documentation and available clinical evidence to identify gaps against EU MDR requirements.
Conduct a systematic literature search using a predefined methodology to identify relevant clinical evidence from recognized scientific sources.
Critically appraise and analyze the collected clinical evidence to determine its quality, relevance, and sufficiency.
Prepare a scientifically justified and MDR-compliant Clinical Evaluation Report based on the evaluated clinical evidence.
Perform an independent technical and regulatory review to ensure the CER is accurate, complete, and submission-ready.
Deliver a finalized Clinical Evaluation Report with all supporting documentation, ready for Notified Body submission and regulatory review.
Our Clinical Evaluation Report (CER) services support a broad range of medical technologies across multiple device categories, ensuring compliance with EU MDR 2017/745 and global regulatory requirements.
Clinical evaluation support for electrically powered and active medical devices.
Clinical evaluation for implantable, reusable, and non-powered medical devices across various therapeutic areas.
Regulatory and clinical evaluation support for software-driven medical technologies and digital health solutions.
Supporting Global Regulatory Compliance Across Markets
Supporting Global Regulatory Compliance Across Markets
Annex XIV, Annex II & III
Clinical Evaluation Guidance
Clinical Evaluation Guidance
Risk Management
Clinical Investigation
Quality Management System
Our dedicated Clinical Evaluation Consultants bring deep expertise across all EU MDR device classes, combining regulatory knowledge, clinical evidence evaluation, and industry best practices to develop compliant, audit-ready CERs that support successful market access and Notified Body expectations.
Experienced multidisciplinary team specializing in medical devices, IVDs, and digital health technologies.
Reports prepared in accordance with current EU MDR requirements and recognized guidance documents.
Evidence-based clinical evaluations supported by comprehensive literature searches and critical appraisal.
From Clinical Evaluation Plan (CEP) through Clinical Evaluation Report (CER), and Notified Body response support.
Supporting manufacturers targeting European and international markets across multiple device technologies.
Expert assistance in addressing Notified Body observations and regulatory queries.
Every deliverable undergoes an independent technical and regulatory quality review.
Tailored clinical evidence strategies to support efficient regulatory pathways and market access.
Comprehensive literature searches using internationally recognized scientific databases and methodologies
Supporting global regulatory submissions across EU, FDA, UKCA, TGA, Health Canada, PMDA, CDSCO, ASEAN, and GCC markets.
Clinical Evaluation Report (CER) for a Syringe & Large Volume Infusion Pump for a Global Medical Device Leader in Infusion Systems and Drug Delivery Technologies
Delivered MDR-compliant clinical evidence demonstrating the safety, performance, and benefit-risk profile of the infusion pump to support regulatory approval and market access.
Clinical Evaluation, Risk Management, and Biological Evaluation Plan and Report for Class IIb and Class III In-vitro fertilization medical devices
Development of Tech File compliant to EU MDR
Development of Tech File compliant to EU MDR
35+ Devices Across All Risk Classes (I, IIa, IIb, III)
US based medical devices company having global footprint
India
A-18, Bhabha Marg, Sector 59, Noida, Uttar Pradesh 201301
India
78/9, 1st Floor, Vaishnavi Signature, Outer Ring Road, Bengaluru 560103
India
CTS No 4944, Magarpatta Road, Kirtane Baugh, Hadapsar, Pune 411013
USA
PO Box 61, Fair Play, South Carolina 29643
USA
16192 Coastal Highway, Lewes, Delaware 19958
India
Karuna Conclave, 3rd Floor, AD 45, Shanthi Colony, Anna Nagar, Chennai 600040
SARACA is a rapidly growing product engineering services company with deep expertise in digital, artificial intelligence, and emerging new technologies. Founded in 2014, SARACA is powered by Gen Z and Millennials with greater focus on agility, customer centricity, faster technology adoption, and adherence to cultural sensitivity. Our digital natives perform their actions with speed and ensure that we exceed customer expectation every single time. SARACA adopted vertically integrated approach to build depth in the industries we operate in. Over the years we have built strong expertise in aerospace, defense, space, automotive, medical devices, Industrial, Farm Equipment, rail transportation, technology, semiconductor, and many other industries.
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