• Preparation and Review of Medical Device and In-Vitro Diagnostic Regulatory Submissions, Applications, Filings, and Amendments such as:
  • USFDA Medical Device Premarket Approval (PMA) Applications
  • USFDA Medical Device Premarket Notification 510(k)s Applications
  • USFDA Medical Device Investigational Device Exemptions (IDE)
  • USFDA Medical Device and In-Vitro Diagnostic Registrations and Listings
  • European Union Technical Files
  • European Common Technical Documents
  Government Liasons
  • Preparation and Attendance for Government Meetings such as:
    • US Food and Drug Administration (FDA) CDRH Medical Devices Advisory and Compliance Meetings
    • Health Canada Medical Device Meetings
    • EU Medical Devices Meeting
• Medical Device Expert Witness and Expert Testimony
• Medical Device Quality Assurance Services such as:
  • Development, Evaluation and Audits of Medical Device Quality Systems
  • Development, Evaluation and Audits of Medical Device Standard Operating Procedures
  • Medical Device Quality Assurance Staffing and Management
  • Development, Evaluation and Audits of Medical Device Design Controls
  • Medical Device Hazard Analysis and Risk Assessment such as Fault Tree Analysis
• Medical Device Regulatory Compliance to Medical Device Governement Laws, Regulations, Guidelines and Industry Standards such as
  • US FDA Medical Device QSR Compliance
  • European Union Medical Device Compliance - CE Marking, Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD), and Active Implantable Medical Device Directive (AIMDD)
  • ISO 9000:2000, ISO 14000, ISO 13485:1997 (EN46001), EN540 Compliance
• Audits of Medical Device Manufacturers, Suppliers, Distributors and Packagers such as:
  • US FDA Medical Device QSIT / GMP Audits
  • Mock FDA Inspections
  • ISO Audits
  • GLP Audits
  • Medical Device Vendor Audits
  • Internal Medical Device Audits
• Medical Device Training and Education such as:
  • US FDA Medical Device QSR Training
  • Medical Device Design Controls Training
  • Medical Device EU MDD and IVDD Training
  • ISO Training
  • Good Laboratory Practices (GLP) Training
  • QSR Training
  • Good Clinical Practices (GCP) Training
  • Medical Device Process Validation Training
• Medical Device Labeling and Promotional Materials
• Medical Device and In-Vitro Diagnostic Equipment Qualification and Validation such as:
  • Medical Device Master Validation Plans
  • Medical Device Validation Protocols
  • Medical Device Validation Procedures
  • Medical Device Sterilization Validation and Qualification
  • Medical Device Process Validation and Qualification
  • Medical Device Cleaning Validation
  • Software Validation and Qualification
  • Part 11 Validation
• Medical Device Clinical Trials Consulting Services such as:
  • Medical Device Preclinical Services
  • Medical Device Clinical Trial Design
  • Medical Device Clinical Trial Protocols
  • Medical Device Clinical Trial Monitoring
  • Evaluation of Medical Device Clinical Data
• Medical Devices CE Marking
• Medical Devices EU Authorized Representative
• Medical Devices US Agent
• Medical Devices Remediation
  • USFDA Medical Device Import Detentions
  • USFDA Medical Device Warning Letters and FDA-483's
• Medical Devices Contract Sterilization
  • Medical Device Gamma Sterilization
  • Medical Device E-Beam Sterilization
  • Medical Device Steam Sterilization
• Medical Device Processes and Systems
  • Medical Devices Packaging
  • Medical Device Research
  • Medical Device Technology Transfer
  • Medical Device Engineering
  • Medical Device Shipping and Warehousing
  • Lyophilization
  • Bioprocessing
  • Extrusion
  • Electronic Assembly
  • Medical Device OEM
• Medical Device Crisis Intervention
  • Medical Device Recalls
  • Medical Device Safety Alerts
• Medical Device Technical Reviews
• Medical Device Technical Writing
• Medical Device Scientific Reviews
• Medical Device Project Management
• Medical Device Expert Witnesses and Expert Testimony

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