Establish effective Quality Systems that work for your company
Quality Systems (GMP/ISO)
Paladin Medical® clients may access our template Quality Policy Manual and corresponding Quality System Procedures which are integrated to conform to both 21 CFR 820 (QSR) and ISO 13485. No need to attempt to maintain two separate quality systems!
Quality System compliance monitoring has increased by both the US FDA and by the foreign competent authorities and their agencies. Keeping up with best practices is time-consuming. We have the experience to train your staff, and serve as your interface with FDA if needed. 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.
Paladin Medical® assures that successful regulatory submissions are supported by FDA-compliant Design Control and Review systems.
Read more about Design Control
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.
Post Submission Compliance
Regulatory compliance is more than getting FDA clearance of the device. Paladin Medical® provides full life-cycle regulatory support. We can help you:
- Submit your first FDA Registration and Device Listing and keep it current
- Prepare for FDA or Notified Body inspections and audits
- Conduct required Management Reviews
- Establish complaint assessment processes which help you document and report Medical Device Reports and Vigilance Reports on time
- Conduct trending of product returns, complaints and nonconformities yielding actionable data
- Assess and document Nonconformance
- Properly identify and execute Corrective and Preventative Actions ( CAPA)
- Determine if you need to make Corrections, Removals or Recalls, and your reporting obligations
- Oversee effective Recalls
- Inspection and Audit Preparation
- Respond to an Inspection Finding (483), how to make sure it is done right the first time
- Respond to a Warning Letter and plan and execute corrections
- Conduct internal and vendor audits, including Contract Manufacturers
As a US Agent (Representative) for our clients who import, we coordinate interactions with the US FDA and keep you aware of changing regulations affecting your product. See Read more about US Agent in SPECIALTY SERVICES