Overview

Our Clients are continually surprised at the speed and level of expertise we are able to mobilize to help solve their problems within Quality and Regulatory. Utilizing Neozene’s breadth of expertise, we are able to effectively diagnose and execute the appropriate solution in a cost effective manner. Whether it is outsourcing of an entire project or adding our Team to yours, Neozene will customize a solution to solve your Quality or Regulatory needs, large or small.

RA Services
FDA Submission

  • PMA
  • 510K
  • Technical Files
  • Design Dossier
  • Device Classification
  • Design Control Advisor
  • EU entry
  • Interviewing International Registrar/Notified Body

EU Submission

  • Technical Files
  • Design Dossier
  • Annual Updates
  • 510K
  • Special 510K
  • PMA
  • PMA Supplements
  • PMA Annual Reports
  • IDE
  • IDE Supplements
  • Post Market PMA Compliance
  • Compliance to EN 980 and ISO 15223 Symbols
  • Product Labeling
  • Collateral Marketing Materials
  • Websites
  • Bench Testing Protocol / Report development and implementation
  • Animal Study Protocol / Report development and implementation
QA Services
  • 21 CFR 820 & ISO 13485 Implementation
  • Document and Data Control
  • Design Control Program
  • UDI implementation
  • QE Testing Program
  • Verification & Validation (V&V) Program
  • QS Metrology (calibration and preventive maintenance)
  • Risk Management Process
  • Failure Mode Effect Criticality Assessment – FMECA Support and execution
  • Complaints and FMECA relationship
  • Internal Auditing Program
  • Auditor Support pre/during/post FDA/NB surveillance audits
  • Mock FDA Inspections
  • Inspection Readiness Programs
  • Supplier Qualification Program
  • Supplier Audit Support
  • Supplier Corrective Action Program – SCAR
  • CAPA/NCR Program Implementation
  • Tracking and Resolution of CAPA
  • Nonconforming Materials Tracking and Resolution
  • Root Cause Investigations
  • Establishing a Company’s Internal Training Program
  • FDA 21 CFR 820 Quality Systems
  • EU ISO/EN 13485 Quality Management Requirements
  • Design Control Requirements
  • Risk Management
  • CAPA/SCAR
  • Root Cause Investigations
  • Good Documentation Practices
Remediation Projects
  • FDA 483 findings
  • Warning letters
  • Consent decrees
  • Previous FDA Reviewers on staff
Training
  • GMP/GCP/GLP/GDP
  • Design Control
  • Risk Management
  • UDI Training
Commercialization
  • Expanding indication for use
  • Revised labeling/marketing materials
  • Letter to Files/Special 510ks
  • Annual Submission reports
  • PMA Supplement
  • Amendment submission
  • MDR/VMDR
  • Complaints Handling
  • CAPA/NCR Management
  • Failure Analysis / Root Cause Analysis
  • RMA
  • Management Review Metrics

Quality

Our experts establish robust, ISO-13485 and FDA quality systems from scratch or upgrade the Quality System or subsystems you already have in place. This includes everything from brainstorming ideas, writing quality manuals, facilitating quality policy projects, initiating quality system infrastructure, and corporate-wide training. In addition, we represent a pool of quality auditors that can review your existing quality system in preparation of regulatory agency inspections, for ISO 13485 certification, or for annual quality requirements.

  • Program & Project Management
  • Design Control: Design History File Audits
  • CAPA
  • Quality Engineering
  • Safety & Performance Testing
  • Requirements Definition & Traceability
  • Supplier Quality Program & Development
  • Human Factors and Usability
  • Risk Management
  • Software Development Process & Quality
  • Applied Statistical Tools Expertise
  • Requirements Definition & Traceability
  • Product Verification/ Validation
  • Process and Cleaning Validation

Regulatory

The Regulatory experts in Neozene can help your organization establish all processes necessary to meet all regulatory requirements. Whether these requirements are for regulatory submissions, licensure, general compliance, and training, our team of experts will efficiently and effectively establish or assist in establishing a regulatory infrastructure that will withstand scrutiny of any regulatory body in the world.

  • Remediation Planning & Implementation
  • US Submissions – PMA, 510K, DeNovo
  • International Submissions – CE Mark, etc.
  • Clinical Support & Analysis – IDE, etc.
  • Quality Systems Compliance
  • Quality Systems Training
  • Medical Device Reporting (MDR)
  • US Inspections, International & Third Party Audits
  • Regulatory Strategy & Consulting
  • Complaint Handling Systems (CHS)
  • Product Recalls or Field Actions
  • Process and Cleaning Validation