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Medical Devices
Global Clinical Evaluation Reports
Reglysis specializes in preparing Global Clinical Evaluation Reports (CER) for medical devices, a critical component of regulatory compliance. CERs involve a detailed assessment of clinical data to evaluate the safety and performance of a medical device. We follow international guidelines to ensure the documentation meets global regulatory requirements, supporting product approval and market access. Our expertise guarantees that all clinical evidence is robust, well-documented, and aligned with the latest standards.
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Medical Device Global Consulting
Reglysis provides expert consulting services to navigate the complexities of the global medical device regulatory landscape. Our Global Consulting solutions guide manufacturers through every stage of the medical device lifecycle, from product development and regulatory strategy to market approval and post-market compliance. With our in-depth knowledge of international regulations, we help ensure products meet the stringent requirements of global markets, facilitating smoother approvals and successful commercialization.
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European Union (EU) Authorized Representative Services
Reglysis offers EU Authorized Representative services to assist non-EU medical device manufacturers in complying with European Union regulations. As an appointed representative, we act as an official liaison between manufacturers and the European regulatory authorities, ensuring that products meet EU requirements for safety and performance. Our services support seamless market entry, help maintain compliance with EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), and ensure ongoing regulatory obligations are met.
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Post-Market Surveillance
Reglysis provides comprehensive Post-Market Surveillance (PMS) services to ensure the ongoing safety and performance of medical devices once they are in the market. Our PMS solutions include monitoring and evaluating product performance, collecting adverse event data, and ensuring compliance with regulatory requirements. We help manufacturers identify and mitigate risks, ensuring continuous compliance with global regulatory standards and safeguarding patient health throughout the product's lifecycle.
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Partner
With Us
By partnering with Reglysis, you ensure that your product progresses smoothly from development to market, minimizing delays and expediting regulatory approvals.