Find 510k Consultants with Specialty

De Novo Pathway Consultants

Find experienced De Novo pathway consultants. Compare regulatory experts specializing in novel medical devices without valid predicates.

PMA Consultants

Find experienced PMA (Premarket Approval) regulatory consultants for Class III medical devices requiring clinical data.

IDE Consultants

Find experienced IDE (Investigational Device Exemption) consultants for clinical trial regulatory support.

Q-Submission Consultants

Find experienced Q-Submission (Pre-Submission) consultants for FDA pre-submission meetings and strategy.

Cardiovascular Device Consultants

Find experienced regulatory consultants specializing in cardiovascular medical devices, including cardiac implants, stents, and cardiovascular diagnostics.

Neurology Device Consultants

Find experienced regulatory consultants specializing in neurology medical devices, including neurostimulation, brain implants, and neurological diagnostics.

IVD Consultants

Find experienced regulatory consultants specializing in IVD (In Vitro Diagnostic) devices, including lab tests, point-of-care diagnostics, and IVD software.

Dental Device Consultants

Find experienced regulatory consultants specializing in dental medical devices, including dental implants, orthodontic devices, and dental diagnostics.

Orthopedic Device Consultants

Find experienced regulatory consultants specializing in orthopedic medical devices, including joint implants, spinal devices, and orthopedic instruments.

Radiology Device Consultants

Find experienced regulatory consultants specializing in radiology medical devices, including imaging equipment, diagnostic radiology, and radiological software.

General Surgery Device Consultants

Find experienced regulatory consultants specializing in general surgery medical devices, including surgical instruments, surgical equipment, and surgical software.

Gastroenterology/Urology Device Consultants

Find experienced regulatory consultants specializing in gastroenterology and urology medical devices, including GI devices, urological implants, and related diagnostics.

OB/GYN Device Consultants

Find experienced regulatory consultants specializing in OB/GYN medical devices, including obstetric devices, gynecological instruments, and women's health diagnostics.

Anesthesiology Device Consultants

Find experienced regulatory consultants specializing in anesthesiology medical devices, including anesthesia equipment, monitoring devices, and anesthesia delivery systems.

Cardiovascular 510(k) Consultants

Find experienced consultants specializing in 510(k) submissions for cardiovascular devices, including cardiac implants, stents, and cardiovascular diagnostics seeking 510(k) clearance.

Neurology 510(k) Consultants

Find experienced consultants specializing in 510(k) submissions for neurology devices, including neurostimulation devices and neurological diagnostics seeking 510(k) clearance.

IVD 510(k) Consultants

Find experienced consultants specializing in 510(k) submissions for IVD devices, including laboratory tests and point-of-care diagnostics seeking 510(k) clearance.

Cardiovascular PMA Consultants

Find experienced consultants specializing in PMA submissions for cardiovascular devices, including cardiac implants and life-sustaining cardiovascular devices requiring PMA approval.

Cardiovascular De Novo Consultants

Find experienced consultants specializing in De Novo classification requests for novel cardiovascular devices without valid predicates, including new cardiac technologies.

Orthopedic 510(k) Consultants

Find experienced consultants specializing in 510(k) submissions for orthopedic devices, including joint implants, spinal devices, and orthopedic instruments seeking 510(k) clearance.

Dental 510(k) Consultants

Find experienced consultants specializing in 510(k) submissions for dental devices, including dental implants, orthodontic devices, and dental diagnostics seeking 510(k) clearance.

Radiology 510(k) Consultants

Find experienced consultants specializing in 510(k) submissions for radiology devices, including imaging equipment and diagnostic radiology devices seeking 510(k) clearance.

Cardiovascular ISO 13485 Consultants

Find experienced consultants specializing in ISO 13485 quality management systems for cardiovascular device companies, including cardiac device QMS implementation and certification.

IVD ISO 13485 Consultants

Find experienced consultants specializing in ISO 13485 quality management systems for IVD device companies, including IVD QMS implementation and certification.

Cardiovascular FDA Mock Audit Consultants

Find experienced consultants specializing in FDA mock audits for cardiovascular device companies, including cardiac device inspection preparation and FDA compliance audits.

IVD FDA Mock Audit Consultants

Find experienced consultants specializing in FDA mock audits for IVD device companies, including IVD inspection preparation and FDA compliance audits.

Dental FDA Mock Audit Consultants

Find experienced consultants specializing in FDA mock audits for dental device companies, including dental device inspection preparation and FDA compliance audits.

Cardiovascular ISO 14971 Consultants

Find experienced consultants specializing in ISO 14971 risk management for cardiovascular devices, including cardiac device risk analysis and risk management files.

IVD ISO 14971 Consultants

Find experienced consultants specializing in ISO 14971 risk management for IVD devices, including diagnostic device risk analysis and risk management files.

Neurology PMA Consultants

Find experienced consultants specializing in PMA submissions for neurology devices, including neurostimulation devices and brain implants requiring PMA approval.

Orthopedic PMA Consultants

Find experienced consultants specializing in PMA submissions for orthopedic devices, including complex orthopedic implants requiring PMA approval.

IVD PMA Consultants

Find experienced consultants specializing in PMA submissions for IVD devices, including high-risk IVD devices and companion diagnostics requiring PMA approval.

Neurology De Novo Consultants

Find experienced consultants specializing in De Novo classification requests for novel neurology devices without valid predicates, including new neurostimulation technologies.

Neurology ISO 13485 Consultants

Find experienced consultants specializing in ISO 13485 quality management systems for neurology device companies, including neurological device QMS implementation.

Orthopedic ISO 13485 Consultants

Find experienced consultants specializing in ISO 13485 quality management systems for orthopedic device companies, including orthopedic device QMS implementation.

Dental ISO 13485 Consultants

Find experienced consultants specializing in ISO 13485 quality management systems for dental device companies, including dental device QMS implementation.

Radiology ISO 13485 Consultants

Find experienced consultants specializing in ISO 13485 quality management systems for radiology device companies, including radiology device QMS implementation.

Neurology FDA Mock Audit Consultants

Find experienced consultants specializing in FDA mock audits for neurology device companies, including neurological device inspection preparation.

Orthopedic FDA Mock Audit Consultants

Find experienced consultants specializing in FDA mock audits for orthopedic device companies, including orthopedic device inspection preparation.

Neurology ISO 14971 Consultants

Find experienced consultants specializing in ISO 14971 risk management for neurology devices, including neurological device risk analysis.

Orthopedic ISO 14971 Consultants

Find experienced consultants specializing in ISO 14971 risk management for orthopedic devices, including orthopedic device risk analysis.

Dental ISO 14971 Consultants

Find experienced consultants specializing in ISO 14971 risk management for dental devices, including dental device risk analysis.

Cardiovascular Predicate Analysis Consultants

Find experienced consultants specializing in predicate device analysis for cardiovascular devices, including cardiac device predicate research and comparison.

IVD Predicate Analysis Consultants

Find experienced consultants specializing in predicate device analysis for IVD devices, including diagnostic device predicate research and comparison.

Cardiovascular Test Strategy Consultants

Find experienced consultants specializing in test strategy development for cardiovascular devices, including cardiac device testing requirements and test planning.

IVD Test Strategy Consultants

Find experienced consultants specializing in test strategy development for IVD devices, including diagnostic device testing requirements and validation planning.

Cardiovascular Classification Consultants

Find experienced consultants specializing in device classification assessment for cardiovascular devices, including cardiac device classification and product code identification.

IVD Classification Consultants

Find experienced consultants specializing in device classification assessment for IVD devices, including IVD device classification and product code identification.

Cardiovascular 510(k) Authoring Consultants

Find experienced consultants specializing in full 510(k) submission authoring for cardiovascular devices, including complete cardiac device 510(k) document preparation.

IVD 510(k) Authoring Consultants

Find experienced consultants specializing in full 510(k) submission authoring for IVD devices, including complete IVD device 510(k) document preparation.

Cardiovascular RTA & Deficiency Support Consultants

Find experienced consultants specializing in RTA and deficiency letter responses for cardiovascular devices, including cardiac device FDA communication management.

IVD RTA & Deficiency Support Consultants

Find experienced consultants specializing in RTA and deficiency letter responses for IVD devices, including IVD device FDA communication management.

Cardiovascular Q-Submission Support Consultants

Find experienced consultants specializing in Q-Submission support for cardiovascular devices, including cardiac device pre-submission meetings and FDA strategy.

IVD Q-Submission Support Consultants

Find experienced consultants specializing in Q-Submission support for IVD devices, including IVD device pre-submission meetings and FDA strategy.

Cardiovascular QMS Setup Consultants

Find experienced consultants specializing in QMS setup for cardiovascular device companies, including cardiac device quality management system implementation.

IVD QMS Setup Consultants

Find experienced consultants specializing in QMS setup for IVD device companies, including IVD device quality management system implementation.

Cardiovascular Post-Market Support Consultants

Find experienced consultants specializing in post-market regulatory support for cardiovascular devices, including cardiac device post-market surveillance and compliance.

IVD Post-Market Support Consultants

Find experienced consultants specializing in post-market regulatory support for IVD devices, including IVD device post-market surveillance and compliance.

SaMD Consultants

Find experienced regulatory consultants specializing in SaMD (Software as a Medical Device), including AI/ML software, mobile health apps, and digital therapeutics.

AI/ML Medical Device Consultants

Find experienced regulatory consultants specializing in AI/ML medical devices, including machine learning diagnostics, AI-powered imaging, and adaptive algorithms.

Mobile Health App Consultants

Find experienced regulatory consultants specializing in mobile health applications, including mHealth apps, mobile medical apps, and smartphone-based medical devices.

Cloud Platform Medical Device Consultants

Find experienced regulatory consultants specializing in cloud-based medical devices, including cloud computing medical devices, telemedicine platforms, and cloud-hosted diagnostics.

Wearable Medical Device Consultants

Find experienced regulatory consultants specializing in wearable medical devices, including wearable patches, smart wearables, and continuous monitoring devices.

Implantable Medical Device Consultants

Find experienced regulatory consultants specializing in implantable medical devices, including implants, implantable sensors, and long-term implantable devices.

IVD Test Device Consultants

Find experienced regulatory consultants specializing in IVD test devices, including diagnostic tests, laboratory tests, and point-of-care IVD tests.

Combination Product Consultants

Find experienced regulatory consultants specializing in combination products, including drug-device combinations, biologic-device combinations, and complex combination products.

SaMD 510(k) Consultants

Find experienced consultants specializing in 510(k) submissions for SaMD (Software as a Medical Device), including mobile health apps and digital therapeutics seeking 510(k) clearance.

AI/ML 510(k) Consultants

Find experienced consultants specializing in 510(k) submissions for AI/ML medical devices, including machine learning diagnostics and AI-powered imaging seeking 510(k) clearance.

Implantable PMA Consultants

Find experienced consultants specializing in PMA submissions for implantable medical devices, including long-term implants and implantable sensors requiring PMA approval.

SaMD De Novo Consultants

Find experienced consultants specializing in De Novo classification requests for novel SaMD devices without valid predicates, including new digital health technologies.

Mobile Health App 510(k) Consultants

Find experienced consultants specializing in 510(k) submissions for mobile health applications, including mHealth apps and smartphone-based medical devices seeking 510(k) clearance.

SaMD ISO 13485 Consultants

Find experienced consultants specializing in ISO 13485 quality management systems for SaMD companies, including software medical device QMS implementation and certification.

SaMD ISO 14971 Consultants

Find experienced consultants specializing in ISO 14971 risk management for SaMD devices, including software medical device risk analysis and risk management files.

SaMD PMA Consultants

Find experienced consultants specializing in PMA submissions for SaMD devices, including high-risk software medical devices requiring PMA approval.

AI/ML De Novo Consultants

Find experienced consultants specializing in De Novo classification requests for novel AI/ML medical devices without valid predicates, including new AI/ML technologies.

Implantable 510(k) Consultants

Find experienced consultants specializing in 510(k) submissions for implantable medical devices, including implants and implantable sensors seeking 510(k) clearance.

Mobile Health App De Novo Consultants

Find experienced consultants specializing in De Novo classification requests for novel mobile health applications without valid predicates, including new mHealth technologies.

Cloud Platform 510(k) Consultants

Find experienced consultants specializing in 510(k) submissions for cloud-based medical devices, including cloud computing medical devices and telemedicine platforms seeking 510(k) clearance.

Wearable Medical Device 510(k) Consultants

Find experienced consultants specializing in 510(k) submissions for wearable medical devices, including wearable patches and smart wearables seeking 510(k) clearance.

Combination Product 510(k) Consultants

Find experienced consultants specializing in 510(k) submissions for combination products, including drug-device combinations seeking 510(k) clearance.

IVD Test 510(k) Consultants

Find experienced consultants specializing in 510(k) submissions for IVD test devices, including diagnostic tests and laboratory tests seeking 510(k) clearance.

AI/ML PMA Consultants

Find experienced consultants specializing in PMA submissions for AI/ML medical devices, including high-risk AI/ML devices requiring PMA approval.

Mobile Health App PMA Consultants

Find experienced consultants specializing in PMA submissions for mobile health applications, including high-risk mHealth apps requiring PMA approval.

Cloud Platform PMA Consultants

Find experienced consultants specializing in PMA submissions for cloud-based medical devices, including high-risk cloud medical devices requiring PMA approval.

Implantable De Novo Consultants

Find experienced consultants specializing in De Novo classification requests for novel implantable medical devices without valid predicates, including new implant technologies.

Wearable Medical Device De Novo Consultants

Find experienced consultants specializing in De Novo classification requests for novel wearable medical devices without valid predicates, including new wearable technologies.

Combination Product PMA Consultants

Find experienced consultants specializing in PMA submissions for combination products, including high-risk drug-device combinations requiring PMA approval.

IVD Test PMA Consultants

Find experienced consultants specializing in PMA submissions for IVD test devices, including high-risk diagnostic tests requiring PMA approval.

SaMD Predicate Analysis Consultants

Find experienced consultants specializing in predicate device analysis for SaMD devices, including software medical device predicate research and comparison.

AI/ML Predicate Analysis Consultants

Find experienced consultants specializing in predicate device analysis for AI/ML medical devices, including AI/ML device predicate research and comparison.

SaMD Test Strategy Consultants

Find experienced consultants specializing in test strategy development for SaMD devices, including software validation, cybersecurity testing, and clinical evaluation.

SaMD Classification Consultants

Find experienced consultants specializing in device classification assessment for SaMD devices, including software medical device classification and regulatory pathway determination.

SaMD 510(k) Authoring Consultants

Find experienced consultants specializing in full 510(k) submission authoring for SaMD devices, including complete software medical device 510(k) document preparation.

SaMD RTA & Deficiency Support Consultants

Find experienced consultants specializing in RTA and deficiency letter responses for SaMD devices, including software medical device FDA communication management.

SaMD Q-Submission Support Consultants

Find experienced consultants specializing in Q-Submission support for SaMD devices, including software medical device pre-submission meetings and FDA strategy.

ISO 13485 Consultants

Find experienced ISO 13485 consultants for medical device quality management systems, QMS implementation, and ISO 13485 certification support.

FDA Mock Audit Consultants

Find experienced FDA mock audit consultants for inspection preparation, 483 warning letter remediation, and FDA compliance audits.

ISO 14971 Consultants

Find experienced ISO 14971 consultants for medical device risk management, risk analysis, and ISO 14971 compliance.

Predicate Analysis Consultants

Find experienced consultants specializing in predicate device analysis and research for 510(k) submissions, including predicate identification, comparison, and substantial equivalence analysis.

Test Strategy Consultants

Find experienced consultants specializing in medical device test strategy development, including biocompatibility testing, performance testing, and regulatory testing requirements.

Device Classification Consultants

Find experienced consultants specializing in medical device classification assessment, including Class I/II/III determination, product code identification, and regulatory pathway selection.

Full 510(k) Authoring Consultants

Find experienced consultants specializing in full 510(k) submission authoring, including complete 510(k) document preparation, eSTAR submission, and comprehensive 510(k) services.

RTA & Deficiency Letter Consultants

Find experienced consultants specializing in RTA (Refuse to Accept) and FDA deficiency letter responses, including RTA remediation, deficiency response, and FDA communication management.

Q-Submission Support Consultants

Find experienced consultants specializing in Q-Submission (Pre-Submission) support, including Q-Sub preparation, FDA pre-submission meetings, and Q-Sub strategy.

QMS Setup Consultants

Find experienced consultants specializing in quality management system (QMS) setup and implementation, including QMS design, QMS documentation, and QMS implementation.

Post-Market Support Consultants

Find experienced consultants specializing in post-market regulatory support, including post-market surveillance, adverse event reporting, and post-market compliance.

Ex-FDA Consultants

Find experienced ex-FDA consultants with insider knowledge of FDA regulatory processes, submission strategies, and agency communication.

Ex-Notified Body Consultants

Find experienced ex-Notified Body consultants with insider knowledge of EU MDR/IVDR certification processes and notified body expectations.