NWRS Personalized Services

Our Services

NWRS’ provides individually customized services for start-up companies up to large Fortune 100 corporations.

We specialize in point-of-care in vitro diagnostic devices, and our staff has backgrounds in R&D, human factors, quality systems, laboratory technology and clinical trials to assist with all phases of product realization, quality assurance and post market surveillance.

Our areas of expertise include:

  • Clinical, Non-Clinical and Flex Study Protocol development
  • Pre-Submissions (Q-subs)
  • Investigational Device Exemptions (IDE)
  • 510(k) and De Novo submissions
  • Premarket applications (PMA)
  • CLIA Waiver Applications
  • Dual 510(k)-CLIA Waiver submissions
  • Breakthrough Devices Program (EAP) requests
  • Quality System management for GMP compliance, CE marking and ISO certification
  • Risk Management
  • Human Factors
  • Labeling and advertising
  • Complaint Handling
  • Post-Marketing Surveillance
  • Recalls, vigilance and adverse event reporting
  • Resolution and Remediation of Warning Letters and Non-Conformance
  • Product and Establishment Registrations
  • US Agent for foreign device companies

NWRS conducts and monitors clinical trials and prepares 510(k) and PMA submissions for class II and III devices, and we have taken companies through successful notified body audits for CE mark, ISO 13485, and CMDCAS certifications.

The NWRS staff takes pride in providing immediate and personalized attention to our clients, and we are sensitive and responsive to deadlines, details, and budgets. NWRS offers competitive rates by minimizing overhead.

STRATEGIC APPROACHES

There are many aspects to successful market entrance for new medical devices. Ensuring that your device design meets FDA performance criteria is critical to both your and our success.

Our background in diagnostics R&D, human factors, risk management and technical aspects of device design, combined with our knowledge of the type of data collection and presentation that the FDA requires, gives us powerful insights into the development pathways that will get you to market sooner.

A poorly planned submission can mean months of costly studies and review cycles. At worst, it means loss of a product investment and expected revenue. We apply our experience to help circumvent issues that the US FDA may raise during reviews to ensure that your device submission is acceptable.

At best, a declined submission means many months of costly studies and rewrites, and repeating the lengthy review cycle of resubmission. At worst, it means loss of a product and its related costs. We help ensure that your device submission is acceptable to the US FDA.

Strategic Planning from Concept to Market
Premarket Notification 510(k) Submissions
  • New products
  • Product/process changes
  • New intended uses
  • Premarket Approval Applications (PMA)
  • New applications
  • Amendments/Supplemental applications
  • Annual Reports
  • Investigational Device Exemptions
  • IDE/pre-IDE submissions
  • Clinical Protocol development
  • Annual Progress Reports
  • CRO Services
    We specialize in In Vitro Diagnostic Devices (IVDD) Point-of-Care use.

    NWRS provides complete CRO services for your device trials, including:

  • Access to qualified Point-of-Care, Certificate of Waiver and Laboratory Clinical Sites and Investigators
  • Clinical protocol writing and case report form (CRF) development
  • IRB Approvals
  • Documented Training, Monitoring and Close Out
  • Database management
  • Data Collection, cleaning and QC
  • Statistical Evaluations
  • Clinical and statistical reports
  • CLIA Waivers
  • Dual 510(k) and CLIA Waiver by Application
  • Access to qualified Certificate of Waiver clinical sites and intended operators
  • From advice to complete turn key services
  • EU Compliance
  • Quality System Readiness Audits and Gap Analyses for ISO 13485:2016 and MDR transition
  • CE Mark
  • Technical Files
  • Labeling and Advertising Review
    FDA Representative/Official Correspondent
    Compliance Crisis Management
  • FDA Warning Letters
  • Recall strategies and management
  • EU MDD Compliance
  • CE Marking
  • Technical Files
  • QUALITY SYSTEMS SERVICES

    Many companies feel constrained by quality system regulations. A quality system should fit like a well-tailored suit, not like a straight jacket. With the global elevation of regulatory standards and directives, it is prudent to build a quality system that is commensurate with the company’s regulatory footprint. NWRS can help!

    We can build custom-tailored solutions and perform internal and inspection-readiness and gap assessment audits for compliance with 21CFR Part 820, MDSAP, MDD and ANVISA requirements.

    US Good Manufacturing Practices
  • Turn key Systems Design
  • Analysis
  • Audit and Inspection
  • Complaint Handling
  • Product and process risk analysis
  • Manufacturing validation plans (place after Analysis)
  • Corrective and Preventive Action Plans (CAPA)
  • Assessments for Pre-Approval Inspections
  • SOPs, Documentation and Implementation
  • 21 CFR Part 820 Quality Systems on-site training (with certificates issued)
  • Risk Management
  • Vendor Audits
    ISO/EN Standards
  • ISO 13485
  • Pre assessment audits
  • System design and documentation
  • ISO 14971 (Risk Analysis)
  • Technical files
  • Training and Education Services
  • US Quality Systems Administration
  • Document Control Practices
  • Design Control
  • Planning for an FDA or ISO inspection
  • How to Get FDA Approvals

    Download our presentation on managing regulatory issues and get FDA approvals.