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
  • Pre-IDE, IDE, Pre-Market 510 (k) Notification and PMA Submissions
  • CE Marking / European Directive (Technical File / Design Dossier)
  • CMDR Licensing - Canada
  • Regulatory Standards Assessment / Gap Analysis
  • Clinical Evaluations (Literature / IDE / Clinical Trials) / Post Market Surveillance
  • Recall Crisis Management / Adverse Event Reporting / Post Market Surveillance
  • Regulatory Deficiencies (483 / Warning Letter / Consent Decree)
  • Liaison with Regulatory Agencies

Quality Management

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 (ISO 13485 / ISO 9001 / Brazil / CMDR / European Directives / FDA QSR / JPAL / Other Global regulatory Requirements)
  • Quality System Remediation
  • Quality System Support / Maintenance
  • Quality System Integration / Quality System Projects
  • Operational Excellence (Six Sigma / Lean / Cost Cutting Measures)
  • Facility Qualification / Manufacturing Transfer Facility Qualification
  • Manufacturing Process and Equipment Validation
  • Supplier Quality and Audits
  • Medical Device GMP – Quality Assurance
  • Cosmetics Good Manufacturing Practices - ISO 22716
  • DAMAS Quality System - NADL

Design & Development

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
  • UDI (Unique Device Identification)
  • Sterilization Validation / Microbiology Assessment / Cleanroom
  • Biocompatibility Risk Assessment
  • Cleaning Validation Assessment / Reusable Medical Devices
  • Medical Device Failure Analysis
  • Packaging Validation and Sterile Packaging Validation (ISO 11607)

Auditing / Training

We offer the Right Path, Right Now® to prepare your organization for the global marketplace today and the future.

  • 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