Common Sense Systems

Regulatory Affairs

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We understand what it takes to be compliant

You know the challenges of getting a new product through the regulatory compliance obstacle course:

  • Multiple governing bodies around the globe,
  • Regulations that change continually,
  • Specifications that are unclear or inconsistent about which products are subject to which regulations,
  • Test lab preparation and management,
  • Voluminous documentation for test labs and regulators (and too little staff to handle it all),
  • Too little time!

That’s where a strong dose of Common Sense can makes all the difference in completing compliance and getting your product to market quickly.

Our regulatory affairs and compliance engineering experts help you get things completed and submitted on time.  We . . .

  • Maintain up-to-date knowledge on regulations that affect medical devices (ex: ISO 13485, ISO 14971, ISO 60601-1 3rd edition, FDA 21 CFR Part 820, IEC 62304),
  • Complete, maintain and submit all required documents and checklists (ex: FDA 510(k)),
  • Modify and resubmit your documentation as needed,
  • Ensure consistency across all related documents,
  • Provide you detailed status tracking of all documentation,
  • Handle adverse events such as MDRs and recalls,
  • Manage facility assessments for audits and certification,
  • Manage and improve CAPA processes

If you could use some Common Sense help getting your product through compliance documentation, contact us today!