Common Sense Systems

Regulatory Affairs

We understand what it takes to be compliant

Many factors complicate proving regulatory compliance on a new medical device:

  • There are multiple governing bodies around the globe,
  • Regulations change frequently,
  • Regulatory requirements are often unclear or are ambiguous,
  • Product test preparation and management may be difficult,
  • Documentation for test labs and regulators is tedious to prepare,
  • There is often a sense that there is not enough time to complete the work properly.

At Common Sense we will help you obtain medical device compliance and get 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.

Let us help you develop your compliance documentation and obtain the required certifications. Contact us today to discuss your specific requirements.