OUR COMPREHENSIVE CER SERVICES
In-Depth Clinical Evaluations
We conduct thorough clinical evaluations of medical devices. This includes a comprehensive review of clinical data, whether from clinical investigations of your device or studies on substantially equivalent devices.
Adherence to MDR Standards
We ensure that our CERs are fully compliant with the MDR requirements. The MDR mandates a detailed approach to clinical evaluations, focusing on specific General Safety and Performance Requirements (GSPRs).
Continuous Updating
Recognizing the dynamic nature of medical device regulation, we continuously update the CERs. This includes integrating new clinical data, post-market surveillance outcomes, and any modifications to the device.
Gap Analysis
We perform gap analyses on existing CERs to identify potential deficiencies and ensure that your documentation aligns with the current regulatory expectations.
Risk-Benefit Analysis
Our evaluations include a detailed risk-benefit analysis, assessing the medical device’s safety and efficacy in the context of its intended patient population and clinical setting.
Detailed Clinical Evidence Compilation
Our team compiles and critically analyzes clinical evidence, ensuring a comprehensive understanding of the device’s performance and safety profile.
Expert Team Involvement
Our experts are equipped with knowledge in medical device evaluation, clinical research, and regulatory affairs, ensuring the accuracy and validation of the CER.
WHY CHOOSE MDS FINLAND FOR YOUR CER NEEDS?
Expertise in MDR Compliance
Our team is well-versed in the new MDR guidelines, providing you with CERs that not only meet regulatory requirements but also contribute to patient safety and medical innovation.
Tailored Evaluations
We understand that each medical device is unique. Our evaluations are tailored to the specific characteristics and intended use of your device.
Proactive Approach
We anticipate the evolving nature of medical device regulations and keep our clients ahead in compliance.
At MDS Finland, our mission is to support the development and maintenance of safe and effective medical devices. Through our detailed and compliant CERs, we contribute to the successful market entry of medical devices and uphold the highest standards of patient safety and care.
