Our services
REGULATORY AFFAIRS
- 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


We offer the Right Path, Right Now® to develop, implement and sustain your Quality Management System for compliance to global regulatory requirements.
QUALITY MANAGEMENT SYSTEMS (QMS)
- 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
- 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)

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

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 in a quality product or service.

We offer the Right Path, Right Now® to ensure a collection of processes and activities to monitor the performance of a product.
POST MARKET SURVEILLANCE (PMS)
- Complaint Handling
- Recall Crisis Management
- Adverse Event Reporting
- Post Market Surveillance Activities
- Post Market Clinical Follow-up Studies (PMCF)
REMEDIATION ACTIVITIES
- 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

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

We offer the Right Path, Right Now® to reduce waste, increase efficiency, and improve internal employee and external customer satisfaction.
CONTINUOUS IMPROVEMENT
- Operational Excellence
- Cost Cutting Measures (Product and Process)
- Total Quality Management (TQM)
- Kaizen
- Lean
- Six Sigma
- CMME
SAFETY
- OSHA
- Dental Lab Safety
- ISO 45001
- ISO 14001
- OHSAS 18001

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