Your Champion for Product Success

Compliance

Establish effective Quality Systems that work for your company

Quality Systems (GMP/ISO)

Paladin Medical® clients have a non-exclusive license to use our template Quality Policy Manual and corresponding Quality System Procedures, which are already integrated to conform to both 21 CFR 820 (QSR) and ISO 13485.i With FDA’s newly announced “integration by adoption” of ISO 13485: 2016, you will be able to smoothly integrate requirements as your company works develops. Quality System compliance does not have to be so difficult! Read more about QSMR in Staying Current.

As a start-up company you may be tempted to subscribe to an eQMS (Electronic Quality Management System) software. Not only is this an expensive undertaking, but all members of the team must be equally trained and deployed or the system goes to waste. We train your employees to quality systems as we deploy the operating procedures and forms at a level appropriate for your business scope and skill sets. Your firm may begin with a “paper-based” quality system and documentation system and use systems such as Adobe in order to distribute the documentation. When it is time or beneficial to move to a fully electronic quality management system, we can help you qualify the eQMS vendor and help you transition your documentation. Part 11: Electronic Records: Electronic Signatures regulations apply, so we can help assure you comply with these rules with either system you use.

Paladin Medical® assures that successful regulatory submissions are supported by FDA-compliant Design Control and Review systems.
Read more about Design Control

Regulatory compliance is more than getting FDA clearance or approval of your device. Paladin Medical® provides full life-cycle regulatory support. We can help you:

  • Assure your Design Transfer documentation passes Review
  • 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 and help you assess compliance using QSIT
  • Establish complaint assessment processes which help you document and report Medical Device Reports
  • Conduct trending of product returns, complaints and nonconformities yielding actionable data
  • Assess and document Nonconformance and Corrective and Preventative Action
  • Execute Corrective and Preventative Actions (CAPA) effectiveness checks
  • Determine if you need to make Corrections, Removals or Recalls, and your FDA reporting obligations
  • Oversee effective Recalls and assist in reporting progress to FDA
  • Respond to an Inspection Finding (483), and 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
  • Part 11: Electronic Records

As a US Agent (Representative) we coordinate interactions with the US FDA and keep you aware of import requirements, dislodge “stuck” product from customs and keep you aware of, changing regulations affecting your product. Read more about US Agent in Strategic Services

iDisclaimer: 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.
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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

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