Compliance

Compliance

Quality System compliance monitoring has increased by both the US FDA & by the foreign competent authorities & their agencies. Keeping up with best practices is time-consuming. We have the experience to train your staff, & serve as your interface with FDA if needed. We can conduct a Quality Systems Gap Analysis following the FDA’s QSIT guidance & provide a priority report for remediation of high priority gaps.

Paladin Medical® assures successful regulatory submissions are supported by FDA-compliant Design Control & Review systems.

Regulatory compliance is more than getting FDA clearance of the device. We provide full life-cycle regulatory support. We help you:

Submit your first FDA Registration & Device Listing and keep it current.
Prepare for FDA/Notified Body inspections & audits.
Conduct required Management Reviews.
Establish complaint assessment processes which help document & report MDR's & Vigilance Reports on time.
Conduct trending of product returns, complaints & nonconformities yielding actionable data.
Assess & document Nonconformance.
Properly identify & execute Corrective and Preventative Actions.
Determine if you need to make Corrections, Removals or Recalls, & your reporting obligations.
Oversee effective Recalls.
Inspection & Audit Preparation.
Respond to an Inspection Finding (483), ensure it is done right the first time.
Respond to a Warning Letter, plan & execute corrections.
Conduct internal & vendor audits, including Contract Manufacturers.