The MDR has ushered in more stringent standards for medical devices in Europe, focusing on safety, quality, and performance. It classifies devices based on their risk profile and imposes stricter conformity requirements for higher-risk classes. Manufacturers are now required to provide extensive pre-market clinical evidence and demonstrate conformity to essential requirements, overseen by notified bodies.
Navigating this transition successfully is crucial to prevent the risk of medical device rejection. Choosing the right regulatory assurance advisor is key to ensuring a smooth process tailored to your needs. At GMRE, we are dedicated to your success and offer added value through our expertise in various areas:
Biocompatibility Risk Assessment (ISO 10993-1): Our team specializes in Biocompatibility Risk Assessment, adhering to ISO 10993-1. This standardizes the chemical and toxicological evaluation of materials used in manufacturing and cleaning processes. Given the MDR’s emphasis on stricter safety rules and testing requirements, our in-depth knowledge of materials’ toxicology is instrumental in rationalizing testing processes, thereby minimizing unnecessary costs.
ISO 13485: We bring extensive experience with ISO 13485, the international standard for quality management systems for medical devices. With significant changes in IQ/QQ/PQ as part of the MDR, our team ensures compliance with stringent requirements for equipment validation, aligning closely with international standards.
Clinical Evaluation, Risk-Benefit Analysis, Packaging, and Sterilization Validation: Leveraging decades of hands-on experience, our team excels in Clinical Evaluation, Literature review, equivalent device assessment, Risk-Benefit Analysis, and Packaging and Sterilization validation (Steam, Gamma, and ETO). We have successfully adapted to multiple changes introduced by the MDR, strengthening devices in terms of quality, safety, documentation, and more.
Partner with GMRE to benefit from our added value services and ensure a seamless transition to compliance with MDR regulations.
