Welcome to the MDR Certification Service Smart Pricing System. This system is designed to provide you with a transparent, customizable, and cost-effective price quote for MDR certification services.

Please follow the steps below to get your instant quote:

1. Select Basic Information

At the top of the page, you need to select two key pieces of information:

• Product Classification: Choose the corresponding risk level for your medical device (Class IIa, IIb, or Class IIb Implantable or Class III).
• Service Type: Select your desired service model.

2. Understand the Three Service Types

• Full Assistance (Writing): Ideal for clients who want comprehensive, end-to-end support. In this mode, the “Core Services” list is fixed (showing “Writing” or “Assist” labels), and you only need to check the “Optional Services” as required.
• Review & Consulting Service: Ideal for clients who already have a draft of the technical documentation and require expert review. In this mode, the “Core Services” list is also fixed (showing “Review” or “Writing” labels), and you will also just check the “Optional Services” as needed.
• Mixed Mode (Custom): The most flexible option. In this mode, both “Core Services” and “Optional Services” will become clickable buttons. You can independently select “Writing,” “Review,” or “Assist” for each service item, allowing for precise budget control.

3. Configure Technical Documentation (TD) Services

• Core Services: In “Full Assistance” or “Review” mode, this is a fixed service list. In “Mixed Mode,” please click the button for the service type you need for each item.
• Optional Services: In “Full Assistance” or “Review” mode, check the boxes for the additional services you need. In “Mixed Mode,” click the buttons to select the service type.
• The “Technical Documentation (TD) Service Subtotal” module will display the real-time total for the TD section.

4. (Optional) Add Independently Calculated Services

Below the TD services, you can select independent service modules as needed. These are billed separately:

• EAR & QMS Services
• Clinical Evaluation Services
• Special Validation Services

Special Note: In “Clinical Evaluation Services,” the “Literature Search” service includes a base fee covering up to 500 articles. If you need to search more, you can use the + and - buttons next to it to add extra fees in increments of 50 articles (¥500 per 50 articles).

5. Review Price Summary

At the very bottom, the “Price Summary” module will clearly list:

• Technical Documentation (TD) Service Total
• Independently Calculated Services Total
• Project Grand Total (Your Final Quote)

Important Note: The price provided by this system is a reference quote. The final price may be adjusted based on the specific complexity, scope, and actual workload of your project. For a detailed consultation, please contact our professional consulting team.