The CEP specifies the scope and depth of the evaluation, detailing the data collection methods, the criteria for acceptability of the data, and the methodology used to appraise the clinical evidence.

Our approach involves a systematic definition of objectives, which are aligned with regulatory requirements and tailored to the specific needs of each device, thereby facilitating a streamlined pathway to compliance and market approval.

CLINICAL EVALUATION PLAN

The CEP is a foundational element of the clinical evaluation process, setting the protocol, strategy, and direction for the Medical Device (MD) assessment. At CERINTIME Tech, we design Clinical Evaluation Plans to ensure a clear and efficient process from the start

CLINICAL EVALUATION REPORT

The CER compiles evidence to demonstrate the safety and performance of a device throughout its expected lifecycle and supports the application for CE marking under the Medical Device Regulation (MDR) 2017/45

At CERINTIME Tech, we specialize in delivering comprehensive Clinical Evaluation Report (CER) writing services meticulously tailored to meet the rigorous demands of the Medical Device Regulation (MDR). Our proactive approach ensures that all documentation not only aligns with MDR timelines but also addresses evolving post-market needs, thereby helping you maintain regulatory compliance and product efficacy.

What is your scenario?

• Non-Existing CER: If you do not currently have a CER, we can create one to facilitate CE marking under MDR.

• CER Under MDD: If your device was previously CE marked under the Medical Device Directive (MDD) and needs to comply with MDR, we can assist in updating your legacy device's CER to meet current (EU) MDR requirements.

• Uncertainty About MDR Compliance: If you are uncertain whether your existing CER complies with MDR criteria, we offer thorough reviews of existing CERs to ensure full compliance with all current regulatory standards.

• Existing MDR CER Needing Updates: For medical devices already CE marked under MDR, we provide CER updating services, which include the refreshment of literature searches to incorporate the latest scientific and clinical insights. We ensure that your CERs remain up-to-date by continuously adapting them to meet evolving regulatory demands.

SPECIFIC LITERATURE SEARCHES

Our expert-driven literature searches deliver unparalleled precision. Tailored for each product category, we ensure your Clinical Evaluations are robust and regulatory-ready

At CERINTIME Tech, we excel in conducting detailed and comprehensive literature searches to meticulously establish the state of the art (SOTA), carefully selecting only the most pertinent databases and publications. This process is tailored specifically to the unique requirements of each product category, ensuring a thorough and precise alignment with industry standards.

In addition to seamlessly integrating these robust searches into our clinical evaluations, we also offer specialized literature search services designed to meet the individual needs of our clients.

Our expert team goes beyond basic compliance, utilizing cutting-edge tools and techniques to deliver insights that not only fulfill regulatory demands but also provide strategic value, helping our clients stay ahead in their respective markets.

CLINICAL NON-CONFORMITY RESOLUTION

Transform challenges into opportunities: Expert guidance for clinical Non-Conformity (NC) resolution

We understand the complexities involved when you receive feedback from a Notified Body regarding clinical Non-Conformities.

The CERINTIME Tech expert team is dedicated to guiding you meticulously through the resolution process, providing targeted assistance with the necessary corrections, and ensuring that your documentation not only meets but exceeds all regulatory standards.

We prioritize a comprehensive approach to compliance, optimizing your submissions to align with current regulatory expectations and enhancing the overall quality of your medical device documentation.

POST-MARKET CLINICAL FOLLOW-UP

Tailored PMCF strategies for continuous Compliance and enhanced patient safety

Post-Market Clinical Follow-Up (PMCF) activities are a cornerstone of sustained clinical evaluation and essential for maintaining regulatory compliance.

At CERINTIME Tech, we specialize in crafting comprehensive PMCF Plans and Reports that adhere to the rigorous demands of Notified Bodies. Our services extend to the development of additional requisite documents, including detailed clinical surveys, ensuring that every clinical aspect is meticulously covered.

Our proactive approach not only satisfies regulatory requirements but also enhances product safety and efficacy, providing ongoing support throughout the product lifecycle.

CLINICAL REGULATORY CONSULTANCY

Our services include providing expert guidance on clinical regulatory compliance tailored to the stringent standards of the Medical Device Regulation (MDR). Our seasoned team is equipped with deep industry and clinical knowledge and expertise to help you effectively navigate the complexities of the regulatory landscape.

We ensure that your medical devices not only meet but exceed the current regulatory requirements, thereby facilitating smoother market entry and sustained compliance. With our proactive approach, we address potential compliance issues before they become obstacles, ensuring that your product's journey from conception to market is seamless and efficient.

We are specialized in providing clinical regulatory guidance to establish the ideal strategy for obtaining CE marking under MDR or maintaining your product on the market. Navigate MDR Compliance with confidence: Partner with CERINTIME Tech