Our Services
Regulatory Compliance
Regulatory Submissions
Regulatory Submissions
- Internal Audits per FDA 21 CFR, ISO 13485 or MDSAP
- Quality Managment Systems - Development, Revision, and Gap Analysis
- Supplier Audits/Qualifications
- Design Documentation Gap Assessments
Regulatory Submissions
Regulatory Submissions
Regulatory Submissions
- Device Classification Research
- Pre-Submission Support
- FDA or Notified Body Correspondence (Audits or Submissions)
- 510k, PMA or Technical File Submissions
- Observation/Removal Responses
Quality
Regulatory Submissions
Project Managment
- Quality Training
- Quality Assurance/Inspections
- Remote Quality Managment - review and approval of inspections, design and development documentation, quality records, change control and much more.
- Environmental Controls
Project Managment
Research & Development Engineering
Project Managment
- Project Planning
- Scope Definition
- Milestone Development
- User & Customer Needs Definition
- Cross Department Coordination
- Project Feasibility Assessment
- Risk Assessment and Evaluation
Research & Development Engineering
Research & Development Engineering
Research & Development Engineering
- Design Consulting
- Specification (2D/3D) Development
- Design Development Documentation (DHF & Technical Files)
- Risk Managment Files
- Verification/Validation Protocols & Reports
- Remediation of Documentation
Operations
Research & Development Engineering
Research & Development Engineering
- Developing Processes
- Developing Work Instructions
- Developing Organizational Policies
- Operations Strategy
- Performance Improvement
- Employee Training
- Supplier Selection
Partnership Services
R&D/Engineering
Distribution & Importing
Quality & Regulatory
- Human Factors/Usability Studies
- 3D CAD and 2D Drawings
- Design for Manufacturing
- Theoretical Stress Analysis (FEA)
- Test Method Development
Quality & Regulatory
Distribution & Importing
Quality & Regulatory
- Global Submissions
- MDR compliance for EU
- MDSAP Compliance
- Notified Body Audits/Responses
Distribution & Importing
Distribution & Importing
Clinical & Lab Test Facilities
- Initial Importer
- Distribution
- Warehousing
- US Agent Representative
- Reimbursement Strategy
Clinical & Lab Test Facilities
Clinical & Lab Test Facilities
Clinical & Lab Test Facilities
- Clinical Reviews & Studies
- Mechanical Testing
- Sterilization Validation
- Software & Cybersecurity Validation
- Biocompatibility Testing
- GLP Test Facilities
Legal & IP
Clinical & Lab Test Facilities
Manufacturing
- Intellectual Property
- Contract Review
- Contract Development
- Firm Establishment
- Company Merger and/or Sale
Manufacturing
Clinical & Lab Test Facilities
Manufacturing
- Prototype Suppliers
- Small Batch Manufacturers
- Strategic Manufacturer Partnering
- Sterilization Services
- Assembly and Packaging Facilities
Business Administration
Business Administration
Business Administration
- Bookkeeping
- Business Registration
- Annual Financial Reporting
- Payroll Processing
Our Partners
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