Medical Product Regulatory Services

Design Control Planning and Review

Reduce costs and time to market with efficient development systems.

All successful regulatory submissions are supported by FDA compliant Design Control and Review systems. Quality System Regulations (21 CFR 820 :QSRs) and ISO 13485 require documented design review according to written procedures, with results maintained in a documentation system (Design History File). Read more about Quality Systems in Compliance

As a start-up medical device project you may need help implementing:

• Quality System documented SOPs
• Design plans
• Design review meetings
• Change control for documentation of changes to design inputs and outputs
• Design History File and development records
• Documented customer inputs
• A documented development plan that supports the product development process
• Design Level Hazard Analysis and Risk Assessment
• Design verification and/or validation tied to risk analysis and technological differences Read more in Qualification
• Soundly crafted output documentation relevant to regulatory submissions and compliant with standards and guidance document requirements
• Design transfer and process validation Read more in Qualification

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Qualification

Plan and execute performance studies with least burdensome methods.

Qualification Planning and Testing requires coordination of the development of protocols with product claims, risk mitigation and performance requirements. Qualification planning pulls together Design Control compliance, regulatory submission requirements, such as development of claims, indication for use and labeling and scientific methods to develop the evidence of Substantial Equivalence and Safety.

Paladin Medical® can help you identify qualified labs and assist your engineering team in the establishment of outcome measures and acceptance criteria. Test articles for qualification testing require characterization prior to testing. We can help you assure you have established and full understanding of the product prior to launching expensive testing.

Verification and Validation is the bedrock of swift pre-market submission. Approval depends upon evidence that the device has been qualified to meet the requirements set forth in the design and quality plan, including compliance with international standards and FDA guidance. Examples of evidence development include:

• Sterilization and packaging validation
• Software and hardware validation
• Bench top and animal testing Read More in Preclinical Study Design
• Shelf-life and durability testing
• Electronic safety testing (EMC and coexistence)
• Biocompatibility Read More about Biocompatibility and Biomaterials in STRATEGIC SERVICES

 
Some devices require animal and clinical studies Read more in Preclinical/Clinical but many now also require Human Factors or Usability Testing. Paladin Medical® provides services at all levels of user study planning, management, and field monitoring. Read more about Human Factors and Usability Studies in STRATEGIC SERVICES

Qualification Planning depends upon a comprehensive Hazard Analysis and Risk Management program compliant with ISO 14971. We help your team identify requirements for the product, identify hazards which may be associated with potential failure to meet those requirements, potential cause and effect and potential methods for mitigation of those hazards. Assessment of potential for Harm, Frequency and Detectability help to define qualification and testing required. Read more about Risk Management in STRATEGIC SERVICES.
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Compliance

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 keep up with the latest issues based 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.

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.Read More

Regulatory Services Post Submission Compliance

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

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. Read more in US Agent in STRATEGIC SERVICES
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For more details about our Medical Product Regulatory Services and customized training, please contact us.

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