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497 Circle Freeway Suite 230

Cincinnati, Ohio 45246

Business Hours

 

Monday - Friday 

8:30am EST - 5:30pm EST

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Medical Devices

MEDICAL DEVICE REGULATIONS

Compliance Insight’s experts in Medical Device Regulations understand the nuances of international and domestic FDA Medical Device Regulations and possess the expertise needed to bring your product to market. We’ll guide you through product development, procedural guidelines, device testing, validation and quality control systems to ensure your product meets all necessary Medical Device Regulations and FDA Standards. Our team works to meet standards established for FDA Medical Device Regulations along with ISO and Quality and Risk Management Systems.

We’ll guide you through product development, procedural guidelines, device testing, validation, and quality control systems, and ensure your product meets all necessary regulatory and FDA standards.

Our specialists work to meet standards established by the FDA, ISO and quality and risk management systems

Experience & Capabilities

  • FDA Compliance Consulting

  • Project Management

  • FDA 483 / Warning Letter

  • Consent Decrees

  • Systems Monitoring

  • GXP Training

  • Product Submissions

  • Due Diligence

  • Product Reviews

  • Registration & Listing

  • Audits

  • Gap Analysis

  • Regulatory Strategies

  • Inspection Preparation

  • GMP Services

  • GCP Services

  • FDA Submissions

  • Clinical Development

  • Nonclinical Development
  • Risk Based Assessment

  • Combination Products

  • Staff Augmentation

  • Electronic Publishing

  • Program Design