It is easy to make mistakes in the regulatory process that can delay market entry or incur unnecessary costs. With help from Tradefield’s medical product RA/QA consultants, you can pursue the most efficient regulatory route to approval and registration for your product.

Determination and assessments

Classifying your medical product is an important first step in the product registration process. Your product class dictates its regulatory roadmap, including required documentation, clinical data and study requirements, safety testing requirements, and more.

We have experience classifying medical products according to rules in many markets. Our team performs the toughest classification assessments for novel, borderline, and combination products. If needed, we will work with you to seek feedback from regulatory authorities on the appropriate classification for your product through pre-submission meetings.

Global market startegy

Because we work in so many different markets, we fully understand complex national regulations and where they overlap. We apply this knowledge for your benefit in a way that could not be achieved by working with separate consultancies or affiliates with limited local expertise. We will develop customized regulatory strategies that leverage your existing registrations. Whether you have one product or hundreds, we can help you expand your market reach to major and emerging markets worldwide.

Achieve QMS compliance

We develop, implement, and maintain integrated quality management systems that comply with QMS regulations in all major markets.

We also assist with gap analyses, due diligence, and internal, supplier, and preassessment audits. Our consultants guide you through every step of the process, including writing quality management system procedures, conducting and monitoring the implementation, and training your employees. We also assist in on-going compliance and maintenance of your QMS following implementation and certification.

RA Consalting

• Market Requirements prior to sales
• Medical Product Registraion
• Licensing Maintenance
• Product Classification
• Product Labeling
• Medical Product Reporting Service
• Import & Export Regulations
• Agent Representative Services
• Global Service

QA Consalting

• Quality System Implementation
• Quality System Maintenance Services
• GAP Analysis Services
• Quality Audits
• Quality Trainings
• Design & Development
• Risk Management ISO 14971
• Process & Production Control
• Process Validation - Sterilization, Packaging, Clean Room, Machinery