Our Services

At A Wright Path®, we view our clients as our business partners and work with you to develop strategies that will best benefit your business. Our partnership is built on excellence, integrity, passion, and social conscience. As your business partners, we will stay abreast of today’s quickly changing regulatory requirements to take your business into the future. Here’s what we will handle for your business to get you on The Right Path, Right Now!

Regulatory Affairs

We offer the Right Path, Right Now® to expedite your products faster to the global marketplace with maximum regulatory efficiency to avoid regulatory hurdles.

  • Regulatory Intelligence
  • Regulatory Strategy
  • Worldwide Registrations and Approvals (Asia / Australia / China / Japan / Latin America) – Medical Devices / Combination Products / Cosmetics
  • Establishment Registration and Device Listing
  • U.S. Designated Agent for Foreign Manufacturers
  • IDE Application, IDE Supplement and Annual IDE Reporting
  • CE Marking / European Directive (Technical File / Design Dossier)
  • 510 (k) Submissions - Traditional, Special and Abbreviated
  • 513 (g) Request
  • de Novo Petition
  • HUD and HDE Application
  • FDA Q-Sub Process
  • CE Marking (Technical File/Design Dossier/STED)
  • CMDR Licensing - Canada
  • Regulatory Standards Assessment / Gap Analysis
  • Clinical Evaluation Process - Clinical Evaluation Reports (CER) MEDDEV 2.7/1 Rev. 4
  • Regulatory Deficiencies (483 / Warning Letter / Consent Decree)
  • Liaison and Communications with Regulatory Agencies
  • Regulatory review of Labeling and Marketing Materials
  • Letter to File
  • FDA Certificates and Permits

Quality Management Systems (QMS)

We offer the Right Path, Right Now® to develop, implement and sustain your Quality Management System for compliance to global regulatory requirements.

  • Quality Management System Development and Implementation
  • FDA Quality System Regulation (QSR)
  • MDD/MDR
  • MDSAP (Australia, Brazil, Canada, United States, Japan)
  • ISO 13485 (2016)
  • ISO 9001 (2015)
  • Cosmetics Good Manufacturing Practices - ISO 22716
  • DAMAS Quality System - NADL
  • Other Global regulatory requirements
  • Quality System Support/Maintenance
  • Quality System Integration/Quality System Projects/Due Diligence

Design Quality Assurance

We offer the Right Path, Right Now® to define global regulatory and customer requirements to ensure compliant products and patient safety.

  • Combination Products (Devices / Drugs / Biologics)
  • Medical Devices / Biologics / Consumer Products / Cosmetics
  • Program Management / Design Controls / Design Transfer / DHF
  • Usability and Human Factors (IEC 62366 and ANSI / AAMI HE75)
  • Safety Risk Management (ISO 14971)
  • Design Assurance / Verification / Validation
  • External Standards and Guidance Maintenance
  • UDI (Unique Device Identification)
  • Sterilization Validation (EO, Gamma, Steam and HPV)
  • Biocompatibility Testing and Risk Assessment
  • Packaging Validation and Sterile Packaging Validation (ISO 11607) 0 (New, Modified, Adoptions)

Quality Assurance

We offer the Right Path, Right Now® to ensure all the planned and systematic activities are implemented within the quality management system to provide confidence of a quality product or service.

  • Manufacturing Process and Equipment Validation
  • pFMEA
  • Facility Qualification/Manufacturing Transfer Facility Qualification
  • Internal Audits
  • Gap Assessments / FDA / Regulatory Body Pre-Audit Preparation
  • Supplier Evaluation / Audits
  • FDA / Regulatory Body Mock Audit Inspections
  • Due Diligence Audit
  • QMS Training and Staff Development
  • Internal Auditor Training
  • DAMAS Training
  • Microbiology Assessment/Cleanroom Monitoring/ Validation
  • Cleaning Process Validation and Assessment/Reusable Medical Devices
  • Medical Device Failure Analysis

Post Market Surveillance (PMS)

We offer the Right Path, Right Now® to ensure a collection of processes and activities to monitor the performance of a product.

  • Complaint Handling
  • Recall Crisis Management
  • Adverse Event Reporting
  • Post Market Surveillance Activities
  • Post Market Clinical Follow-up Studies (PMCF)

Remediation Activities

We offer the Right Path, Right Now® to ensure a quality plan to define remediation activities, root cause and corrective action as well as risk during remediation activity.

  • QMS - Quality Management System
  • DHF - Design History File
  • Technical Documentation - Technical File, Design Dossier, STED
  • 510 (k) Catch Up and Assessment
  • Quality Plan and Associated Risk
  • Root Cause and CAPA

Continuous Improvement

We offer the Right Path, Right Now® to reduce waste, increase efficiency and increase internal employee and external customer satisfaction.

  • Operational Excellence
  • Cost Cutting Measures (Product and Process)
  • Total Quality Management (TQM)
  • Kaizen
  • Lean
  • Six Sigma
  • CMME

Safety

We offer the Right Path, Right Now® to develop and implement policies, and to ensure that procedures are in place for the safety and health of employees within a workplace.

  • OSHA
  • Dental Lab Safety
  • ISO 45001
  • ISO 14001
  • OHSAS 18001