Regulatory Solutions, Not Roadblocks

Strategic regulatory planning and comprehensive 510(k) submission support, including predicate identification, regulatory pathway assessments, substantial equivalence evaluations, submission preparation, and FDA interactions. We support Traditional, Special, De Novo, and Abbreviated 510(k) submissions, as well as responses to FDA requests for additional information, helping clients navigate the review process and achieve clearance. 

Strategic regulatory planning and comprehensive 510(k) submission support, including predicate identification, regulatory pathway assessments, substantial equivalence evaluations, and submission preparation.

Experienced in FDA eSTAR submissions, including preparation and electronic submission of Traditional, Special, and De Novo 510(k)s. We also support FDA interactions and responses to requests for additional information, guiding clients through the review process, and ultimately clearance.

 Comprehensive regulatory strategy and submission support for Class III medical devices, spanning the full Premarket Approval (PMA) lifecycle. Our services include regulatory pathway assessments, PMA development and preparation, original PMA applications, modular submissions, and PMA supplements addressing manufacturing changes, design modifications, labeling updates, and other post-approval changes. We also provide strategic guidance on clinical and nonclinical evidence requirements, FDA interactions, responses to requests for additional information, and ongoing post-approval regulatory obligations. Our experience helps clients navigate complex FDA requirements while maintaining compliance throughout the product lifecycle.

Strategic regulatory guidance for innovative medical technologies, including  Pre-Submission (Q-Sub) planning and preparation, De Novo classification requests, and Breakthrough Device designation. We work closely with clients to develop regulatory strategies, define appropriate clinical and nonclinical evidence requirements, and prepare focused questions to obtain meaningful FDA feedback. 

MedLogics can lead FDA interactions and negotiations, helping clients address regulatory concerns, resolve differences in technical and scientific approaches, and establish clear development and submission pathways. 

We also help clients develop scientifically justified, risk-based test strategies that leverage existing data and evidence to minimize unnecessary testing, where appropriate, 

 Comprehensive regulatory strategy and market access support for medical devices and diagnostics seeking entry into international markets. We provide guidance on global regulatory requirements, market entry strategies, registration pathways, and submission requirements across the United States, European Union, and other international markets that allow leveraging of the CE Mark or FDA approvals. 

Our expertise includes EU MDR and IVDR compliance, technical documentation development and remediation, gap assessments , Notified Body interactions, and coordination of international regulatory submissions. 

We also assist clients with regulatory assessments for international market expansion, changes to existing products, and ongoing compliance with evolving global  requirements. 

We'll support you from concept, to approval and beyond.  MedLogics assists clients with the development, implementation, assessment, and remediation of quality management systems to meet domestic and international requirements, including ISO 13485, FDA's  Quality Management System Regulation (QMSR), and EU MDR. 

 Our services include quality system assessments, gap analyses, internal audit support, CAPA development and remediation, design controls, risk management, supplier quality oversight, validation strategies, and regulatory inspection readiness. We also provide regulatory and quality oversight for contract manufacturing arrangements, manufacturing transfers, process changes, and supplier transitions, helping clients maintain compliance while supporting operational and commercial objectives.

We support software-enabled medical devices, Software as a Medical Device (SaMD), connected technologies, digital health products and apps, robotic platforms, and artificial intelligence (AI) and machine learning (ML)-enabled medical technologies. 

MedLogics provides guidance on FDA expectations for software documentation, design controls, software verification and validation, cybersecurity risk management, and premarket submission requirements. Our expertise includes FDA cybersecurity requirements, including Section 524B of the FD&C Act, premarket cybersecurity documentation, risk assessments, and postmarket cybersecurity considerations. 

We help clients navigate evolving regulatory expectations for software and emerging technologies while developing risk-based strategies that support product development, regulatory submissions, and ongoing compliance.