Regulatory Compliance

Medical device compliance is more than getting FDA clearance of the device. Companies must maintain a steady program of regulatory compliance.  Paladin Medical provides full life-cycle regulatory support and works with your staff to get things done or can provide full services.

  • How to submit your first FDA registration and Device Listing and how to keep it current
  • How to conduct required Management Reviews to effectively monitor compliance and document actions
  • How to establish a compliant complaint assessment process and promptly document and report MDR and Vigilance (OUS) on time
  • How to conduct trending of returns, complaints and nonconformities to yield actionable data
  • How to define and document Nonconformance and differentiate Corrective and Preventative Actions ( CAPA)
  • How to determine if you need to make Corrections, Removals or Recalls and your reporting obligations
  • How to respond to an Inspection Finding (483), how to make sure it’s done right the first time.
  • How to respond to a Warning Letter: planning and executing corrections
  • How to conduct internal and vendor audits, including Contract Manufacturers- reporting to Management
  • How as a US Representative to importers, we coordinate interactions with the US FDA and keep you aware of changing regulations affecting your product

 

Quality Systems (GMP/ISO)

Paladin Medical clients have access to our template Quality Policy Manual and corresponding Quality System Procedures which are integrated to conform to both QSR 820 and ISO 13485.  No need to attempt to maintain two separate quality systems!

Disclaimer: The Paladin Medical regulatory templates are intended for guidance and training only. It is the client’s obligation to maintain and review these documents for conformance to current regulations because each client’s regulatory compliance needs are unique. Clients of Paladin Medical are granted permission to modify these documents to conform to the client’s own policies and document formats. All other rights reserved. Paladin Medical makes no warrants as to the suitability of these documents for specific client requirements or to changes in regulatory policies, regulations, or standards which may occur.

  • Quality System compliance monitoring has increased and keeping up with best practices is time-consuming. We have the experience to train your staff, serve as the interface with FDA.
  • We can conduct a Quality Systems Gap Analysis following the FDA’s QSIT guidance and provide a priority report for remediation of high priority gaps
  • If you prefer, we can edit your existing manual to conform to best practices.   Among the various important segments, we work with you to improve
    • Risk assessment, risk analysis, FMEA.
    • Design History File and Design Transfer.
    • Change Control for Design or Processes.
    • Management Reviews.
    • Quality Planning.
    • CAPA procedures, forms and training.