Some of the services we offer:
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CE Marking
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510(k) clearances
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Health Canada MDL
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Cybersecurity Guidance
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Strategic Regulatory Pathway Planning
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Complaint & MDR Support
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eQMS Implementation
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Risk Management Support
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General Product Commercialization Guidance
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Quality Management System Creation
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21 CFR Part 820 Quality Management System Maintenance
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FDA Investigation Preparation
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Notified Body Audit Preparation
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ISO 13485 Initial Certification Support
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Supplier Management Support
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Foreign Exporter/Initial Importer/FDA Customs Support
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Artificial Intelligence / Machine Learning Guidance
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510(k) AINN Remediation
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SaMD & SiMD
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FDA QMSR Final Rule transition Support
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Internal Auditing
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ISO 13485 Certificate Maintenance
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MDSAP Initial Certification Support
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MDSAP Certificate Maintenance
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Quality & Regulatory Training
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FDA Establishment Registration Support & Guidance
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Labeling and Marketing Material Review
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Recall Management
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510(k) Presubmissions
Note: This list is non-exhaustive, please Contact us if there are any Custom Services you would like to request. Thanks!