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Some of the services we offer:

  • CE Marking

  • 510(k) clearances

  • Health Canada MDL 

  • Cybersecurity Guidance

  • Strategic Regulatory Pathway Planning

  • Complaint & MDR Support

  • eQMS Implementation

  • Risk Management Support

  • General Product Commercialization Guidance

  • Quality Management System Creation

  • 21 CFR Part 820 Quality Management System Maintenance

  • FDA Investigation Preparation

  • Notified Body Audit Preparation

  • ISO 13485 Initial Certification Support

  • Supplier Management Support

  • Foreign Exporter/Initial Importer/FDA Customs Support

  • Artificial Intelligence / Machine Learning Guidance

  • 510(k) AINN Remediation

  • SaMD & SiMD

  • FDA QMSR Final Rule transition Support

  • Internal Auditing

  • ISO 13485 Certificate Maintenance

  • MDSAP Initial Certification Support

  • MDSAP Certificate Maintenance

  • Quality & Regulatory Training 

  • FDA Establishment Registration Support & Guidance

  • Labeling and Marketing Material  Review

  • Recall Management 

  • 510(k) Presubmissions 

Note: This list is non-exhaustive, please Contact us if there are any Custom Services you would like to request. Thanks!

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