Medical Devices

  • Program & Project Planning

  • Resource Allocation & Management

  • Budget Establishment, Analysis & Tracking

  • Project Scope Definition

  • Coach, Mentor & Train others PMs

  • Functional Leaders & Team Members

  • Success Measures & Metrics (Dashboards)

  • Assessments

  • PMO & PPM

  • Help develop your DFM & AS

  • Environmental PFMEAS

  • Quality Management Systems

  • Deviation & CAPA Management

  • Process Design, Harmonization & Validation

  • QA/QC

  • Remediation Services

  • Unique Device Identification (UDI)

  • Design History File (DHF)

  • Device Master File (DMF) & Device Master Record (DMR)

  • Validation

  • Mock FDA Audits 

  • Sterilization

  • Computer Systems Validation

  • Clinical Trial

  • Product Development Process

  • Total Quality by Design

  • Process Development

  • Design Controls

  • Risk Management 

  • Quality Management System (QMS)

  • GMP

  • Baseline or Gap Assessment

  • Inspection Readiness

  • MDSAP Compliance Readiness Assessments

  • Supplier/Distributor

  • Contract Manufacturer

  • ISO 9001, 13485, 14971

  • 21 CFR Part 820

  • 21 CFR Part 11

  • Auditor Training

  • Operations & Manufacturing Strategy & Process Excellence

  • Technical Transfer

  • Innovation & Product Development

  • Sourcing & Procurement

  • Integrated Planning & Analytics, Logistics, Quality & Supplier Compliance 

  • Knowledge Capital

  • Implementation Accelerators

  • Analytics & Mobility

  • Control Towers

  • Contract Manufacturing 

  • Six Sigma

  • TPM

  • Supplier Audits & Remediation

  • FDA (483 Observations, Warning Letters, COnsent Decrees) Remediation

  • Submissions (Premarket Approval PMA, 510 (k), CE Mark & Compliance

  • Technical File & Design Dossier Preparation

  • Labeling, Packaging, Advertising & Promotional Materials

  • UDI

  • Global Regulatory Needs

  • Health Economics & Outcomes Research (HEOR)

  • Compliance

  • Medical Safety Development

  • Information Services

  • Communications

  • New MDR Requirements

  • Education

  • Program/Project Management

  • Quality System Gap Assessment

  • Product Gap Assessment

  • Creation/generation of complaint procedures, work instructions and templates to support a compliant MDR and/or IVDR system

  • Workshop facilitation, training and communication

  • Remediation: Post-Market Surveillance, Clinical Evaluation Reports, Product Technical Files and Design Dossiers