Accurate Consultants Inc.

Accurate Consultants Inc. is a specialized FDA regulatory consulting firm that has served medical device, pharmaceutical, and combination product manufacturers since 1999. The firm provides regulatory affairs, quality systems, and compliance services with particular expertise in FDA submissions and international regulatory pathways.

The company's core capabilities span the entire product lifecycle, including 510(k) and PMA submissions, Quality Management System development and implementation per FDA QSR and ISO 13485:2016 standards, clinical trial support, and compliance remediation. The firm has completed over 500 projects for 90+ clients, with documented experience mitigating 25+ FDA Warning Letters and achieving successful FDA clearances for medical devices ranging from oxygenators to examination gloves.

The team includes credentialed professionals with deep expertise in microbiology, sterile manufacturing, EU regulatory requirements, and quality systems auditing. The firm serves both domestic and international manufacturers requiring U.S. market access or facing FDA compliance challenges.

Choose Accurate Consultants when facing significant FDA compliance challenges, including Warning Letters, 483 observations, or product holds that require proven remediation expertise. The firm's 25-year track record and documented FDA clearances indicate capability to navigate complex regulatory situations rather than routine submissions.

The engagement model appears best suited for organizations needing embedded regulatory and quality expertise for specific projects—from initial QMS development through market clearance—or ongoing compliance management including FDA U.S. Agent representation for international manufacturers.

Accurate Consultants exclusively serves FDA-regulated healthcare product manufacturers, with 100% focus on medical devices (Class I-III), in vitro diagnostics, pharmaceutical products, biologics, and combination products. The firm's expertise addresses the specific compliance requirements of sterile manufacturing, biocompatibility testing, clinical trial design for investigational devices, and post-market surveillance including MDR reporting.

The team's healthcare specialization extends to specific verticals including cardiovascular devices (oxygenators), surgical products, diagnostic equipment, and parenteral pharmaceutical manufacturing with aseptic processing expertise.

Medical device manufacturers (particularly sterile devices, combination products, and IVDs) requiring FDA 510(k) submissions, QMS development from the ground up, or remediation of existing FDA compliance issues. International manufacturers seeking U.S. market entry who need U.S. Agent services and comprehensive regulatory strategy. Companies facing FDA enforcement actions who need experienced consultants with documented Warning Letter resolution success.