FDA Regulatory Consultants

Medical device manufacturers developing orthopedic, spinal, or Class I-III implantable devices requiring mechanical testing and FDA regulatory support. Particularly suited for companies needing comprehensive services from prototype machining through regulatory submission, and those seeking to expedite 510(k) clearance timelines.

Medical device manufacturers and pharmaceutical companies expanding into Asia-Pacific markets, particularly those navigating complex multi-country regulatory landscapes. Well-suited for companies requiring in-country representation, license holding services, and local regulatory expertise. Appropriate for both established MedTech companies and emerging healthcare technology startups needing guidance on ISO 13485 compliance and technical file preparation.

Medical device manufacturers, pharmaceutical companies developing combination products, and biotechnology firms seeking FDA clearance or international regulatory approval. Particularly well-suited for startups and emerging companies navigating their first regulatory submissions, as well as established firms requiring specialized expertise in Breakthrough Device designations or complex clinical trial design.

Accurate Consultants is best suited for medical device, IVD, and pharmaceutical manufacturers navigating FDA regulatory pathways, particularly those requiring 510(k) submissions, QMS implementation, or remediation of FDA compliance issues. The firm serves both established manufacturers and smaller companies entering the U.S. market for the first time, including international manufacturers requiring U.S. Agent services.

Medical device manufacturers and AI/ML health technology startups seeking FDA regulatory approval, particularly those developing software as a medical device (SaMD), digital health products, or Class II/III devices requiring 510(k), De Novo, or PMA submissions. Especially suited for international companies needing a U.S. regulatory agent and companies facing FDA deficiency letters or inspection challenges.

Medical device manufacturers seeking expedited FDA 510(k) clearance for eligible devices across anesthesiology, cardiovascular, dental, gastroenterology, neurology, obstetrics/gynecology, ophthalmic, orthopedic, physical medicine, and radiology categories. Well-suited for both established global manufacturers and emerging companies requiring expert regulatory guidance to accelerate time to market.

Medical device and IVD manufacturers seeking regulatory approval in multiple global markets, particularly companies navigating EU MDR/IVDR transitions or FDA submissions. Well-suited for both established medical technology companies managing complex regulatory portfolios and emerging firms requiring guidance through initial market access.

Medical device startups and small-to-midsize Medtech companies seeking practical QMS implementation without excessive bureaucracy. Particularly suited for organizations pursuing FDA clearance, ISO 13485 certification, or CE marking who need experienced guidance to build appropriate quality systems from the ground up or streamline existing processes.

Medical device manufacturers seeking FDA 510(k) clearance, particularly those requiring hand-delivered submissions and rapid response capabilities during interactive FDA reviews. Well-suited for both emerging companies bringing their first device to market and established manufacturers expanding product portfolios across multiple device classifications.

AltaQ is best suited for IVD/LDT companies, medical device manufacturers, and pharmaceutical organizations requiring specialized regulatory and quality compliance support for FDA submissions and international market access. The firm serves both established companies navigating complex regulatory pathways and organizations seeking to implement or optimize quality management systems aligned with CLIA/CAP, FDA QMSR, or ISO 13485 standards.

Vision28 is well-suited for medical device companies navigating FDA regulatory pathways, particularly startups and small to mid-sized manufacturers seeking 510(k) clearance or quality system establishment. Companies facing FDA 483 observations, warning letters, or product recalls may benefit from their crisis response expertise. Organizations expanding into Canadian or European markets requiring multi-jurisdictional regulatory compliance should also consider their services.

Medical device manufacturers seeking regulatory compliance support in multiple markets, particularly startups and SMEs navigating EU MDR, UK MHRA, or FDA requirements. Companies needing QMS implementation or clinical evaluation support, and larger manufacturers looking to supplement internal regulatory teams with specialized external expertise.

Medical device and pharmaceutical companies seeking FDA regulatory legal counsel, particularly those navigating complex submission pathways like 510(k)s or PMAs. Well-suited for manufacturers and distributors requiring strategic regulatory guidance for both domestic and international market access.

Small to mid-size medical device manufacturers and healthcare startups preparing FDA 510(k) submissions or De Novo classification requests. Companies needing to establish ISO 13485-compliant quality management systems or requiring time-critical regulatory pathways benefit from their structured approach and fixed-fee pricing model.

MedTech manufacturers seeking EU market entry under MDR/IVDR who need external PRRC support, startups requiring regulatory strategy before first submission, and non-US device makers entering the United States who need FDA Agent representation and 510(k) pathway guidance. Particularly suited to companies that need audit-ready documentation and notified body preparation.

KN Consulting is best suited for medical device and IVD manufacturers seeking regulatory approval in multiple markets simultaneously, particularly those targeting US, European, and Canadian markets. The firm is well-positioned to support mid-sized medical device companies and healthcare technology startups that need expert regulatory guidance but may not have in-house regulatory affairs departments. Companies facing complex classification questions, EU MDR/IVDR transitions, or tight submission deadlines will find their specialized expertise valuable.

Medical device manufacturers seeking regulatory approval in US and European markets, particularly startups and emerging companies building their first Quality Management Systems or navigating initial FDA submissions. Also well-suited for established device companies requiring remediation support following FDA 483 observations or managing post-acquisition integration projects.

MCRA is best suited for medical device manufacturers, diagnostics companies, and biologics developers seeking specialized regulatory and clinical expertise. The firm serves companies at all stages, from early-stage startups developing first-in-class devices to established manufacturers navigating complex regulatory pathways or international expansion. Organizations requiring integrated support across regulatory strategy, clinical trials, reimbursement, and quality systems will benefit from their comprehensive approach.

Medical device manufacturers navigating FDA 510(k), PMA, or EU-MDR submission processes. Particularly suited for early-stage startups requiring comprehensive regulatory strategy reports for investor presentations and companies developing novel devices including AI/ML applications, cardiac monitoring systems, and orthopedic solutions.

Start-up and mid-sized medical device companies seeking ISO 13485 certification, FDA approval, or EU MDR compliance. Organizations needing temporary quality system expertise, audit support, or help establishing CAPA programs without hiring full-time regulatory staff.

Medical device manufacturers, pharmaceutical companies, and diagnostic product developers requiring regulatory compliance support and quality system expertise. Particularly well-suited for MedTech startups establishing their first quality systems, companies preparing for FDA submissions, and organizations responding to regulatory findings or observations.

Medical device startups and growth-stage companies that need expert guidance navigating FDA 510(k), PMA, or EU MDR pathways. Particularly well-suited for companies developing software as a medical device, combination products, or complex devices requiring strategic regulatory planning and submission preparation support.

Medical device manufacturers, pharmaceutical and biotech companies, diagnostic developers, and digital health startups seeking specialized regulatory and clinical expertise. Particularly well-suited for companies navigating FDA approval pathways, preparing for regulatory inspections, or requiring strategic guidance on clinical development and market access.

Kandih Bioscience serves pharmaceutical and medical device companies requiring toxicology expertise for regulatory submissions. The firm is particularly suited for organizations developing drugs, biologics, or combination products who need support navigating FDA, EMA, and Health Canada requirements during the preclinical and IND-enabling stages of development.

Information about the ideal customer profile for Exemplar Compliance is not available due to their inactive website. Organizations interested in healthcare compliance services would need to contact the company directly to determine fit.