21 Jul 2025
Regulatory Training and Support We provide training and support to MedTech companies on global regulatory requirements, best practices, and industry standards across the value chain for a wide range of products.
21 Jul 2025
Medical Writing Services We provide comprehensive medical writing services for medical devices and diagnostics, including authoring, review and finalization of essential regulatory documents to help them meet agency compliance criteria.
21 Jul 2025
Post-Market Surveillance Services We offer Post Market Surveillance services to help companies monitor and maintain compliance with post launch regulatory requirements including adverse events and product labeling updates.
21 Jul 2025
Post Market Surveillance Services We offer Post Market Surveillance services to help companies monitor and maintain compliance with post launch regulatory requirements including adverse events and product labeling updates.
21 Jul 2025
Quality Management System (QMS) We provide end-to-end Quality Management System (QMS) services to help companies establish and maintain a robust and effective system for ensuring the quality, performance and safety of their products.
21 Jul 2025
Global Regulatory Submissions 510(k) and PMA submissions: Our team of experts provide end to end support in preparing a comprehensive 510(k) submission, including the development of a regulatory strategy, compilation of technical information, and preparation of all necessary documentation, finalization of the submission package and electronic submission to FDA. The support also includes collation of queries from FDA and technical support...
21 Jul 2025
Global Product Registration Services We provide end-to-end support to MedTech companies for preparation and submission of regulatory applications including Conformité Européene (CE) Technical Files, 510(k) submissions, Premarket Approval (PMA) applications, Health Canada Medical Device License (MDL) applications and other regulatory filings for global markets.
21 Jul 2025
Pre-submission Services Pre-submission meetings with the FDA and other regulatory agencies are an important aspect of the medical device regulatory process. It is an important opportunity for medical device manufacturers to discuss their product and regulatory strategy with the FDA and other Health Authorities and receive feedback on the best path forward. We offer multiple services under this category Pre-sub...
21 Jul 2025
Regulatory Strategy Development Bringing a medical device to market can be a complex and challenging process. With the increasing demand for medical devices and the growing need for regulatory compliance, it is becoming more important than ever to have a solid regulatory strategy in place. MedTechRxL Regulatory Team can help you navigate the regulatory landscape and bring your innovative product...
21 Jul 2025
Regulatory Strategy and Consulting We offer focused regulatory strategy and consulting support to our global MedTech clients for navigating global regulatory barriers across their product lifecycle. This service equips global MedTech companies to drive critical business goals such as time to market and cost efficiency.
RxLogix provides industry's best solutions to the ever-changing drug safety & pharmacovigilance
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