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Regulatory Compliance Consulting

International Regulatory Support

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have requirements for medical devices that can be challenging for many organizations to navigate. If your device requires a CE mark, or if you need to submit a 510(k)/de novo Pre-Market Notification, we can help. We'll guide you through these agencies' complex processes and work closely with you to make the necessary submissions.
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Services offered:

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Strategy Development

International regulatory requirements can have far-reaching implications for many companies. IUVO Consulting will work with your leadership team to evaluate your regulatory strategy in light of your company's pipeline of products. We can help you design a strategy that will help ensure that your medical device business continues uninterrupted. Our advice will help strengthen your team's regulatory knowledge and will help you avoid common compliance pitfalls.
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Contact us today for a free consultation.
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As your company's compliance consultant, IUVO Consulting will assist with required submissions and facilitate effective, productive communications between your company and regulatory agencies. Unlike other firms, which charge by the hour or which charge high fees for minimal service, we work on a flat-rate basis, based on each individual compliance project. This means that you receive the highest level of service, with full control over and knowledge regarding the associated fees.
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To begin, complete the form below or contact us by phone (+1-646-801-4332). We will respond to your inquiry promptly.

We can help you...

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  • ISO 9001 Compliance 

  • ISO 13485 Certification & Auditing 

  • ISO 17025 Certification & Auditing

  • ISO 62304 Compliance & Auditing 

  • U.S. FDA MDSAP

  • GMP Compliance   

  • CAP/CLIA Implementation & Accreditation 

  • GLP Compliance 

  • ISO 15189 Compliance

  • EU Medical Device/IVDD CE Marking

  • EU Authorized Representative

  • Research Study Experimental Design & Technical Submission Review

  • Health Canada Medical Device Establishment License Applications

  • Internal/External Auditing Support

  • Country-Specific Product Registration

  • U.S. FDA Pre-Submission Meeting Requests

  • U.S. FDA 513(g) Requests for Information

  • U.S. FDA 510(k) Pre-Market Notification

  • U.S. FDA de novo Submissions

  • U.S. FDA Pre-Market Applications (PMA)

  • Post-Market Surveillance

Contact us today for a free consultation

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