Tradefield specializes in Regulatory & Quality consultation for medical companies. Our range of services offers complete solutions for Quality System Implementation, Design & Development Services, and Medical Product Registration all over the world. Our goal is to ensure your company and your medical products will meet the applicable regulations and specifications.
Tradefield, LLC will assist you to achieve your market targets.
We have 15 years of experience in the medical field.
Our competence in Regulatory & Quality activities has led to successful worldwide registration and successful quality system implementation.
Your Benefits of working with Tradefield Medical Registration:
- Working with an experienced company.
- Enabling you to enter worldwide markets easily and efficiently.
- Ensuring your quality systems and medical devices will comply with all applicable regulations and specifications.
- Providing you with all required regulations before entering the target market. ensuring confidentiality of your Intellectual Property will be maintained.
- We will work with you and guide you through the entire project until your goals are achieved.
- We will provide you with a fixed price to your defined requirements.
Our Expertise
Regulatory & Legal Activities
- Medical Product Registration, Worldwide Experience
- Governmental Licensing
- Distributors: Search and Contract Handling
- European Representative Services
- Import & Export Regulations
- Trademark & Patent guidance
Quality activities
- Quality System Implementation, Worldwide Experience
- ISO Implementation: ISO 13485, ISO 9001, ISO 22716
- Technical File, CE: Establishment & Maintenance
- Risk Management: ISO 14971, Establishment & Maintenance
- Design & Development
- Design Control File, DHF, DHR, Establishment
- Product Testing
- Validation Programs
- Clinical Evaluations
- Clean Room
- QC Inspections
- Labeling
- Audits
- Trainings
