EN/ISO13485 Certification for a Chinese Manufacturer

The Situation

A China-based manufacturer of Class I, IIa, IIb, and III (implantable) medical devices wants to be certified as an EU vendor in eight months or less.

The Solution

Among other things, RQMIS custom designed a quality system and negotiated with the Notified Body to successfully pass the certification audit in the timeline specified. The China-based manufacturer now has a fully operational company in the EU, which is EN/ ISO13485 Certified.

RQMIS helps a China-based orthopedic company establish German operations and gain EN/ISO13485 Certification


After interviewing customers, RQMIS utilized process flowcharting to lay out the overall operational processes. Once the flowcharts were finalized we developed the documents to complement the flowcharts. These included the Quality Manual, SOPS, WIs, and Forms. All forms were pdf-based forms for ease of use.

Since the majority of the products were being sourced from OEMs a comprehensive Quality Agreement was established to place the appropriate controls on Supplier Quality.

After the core structure of the Quality System was established a Management Review (the 1st) was utilized to walk through each document to assure it reflected the needs of the customer.

RQMIS chose and negotiated with the Notified Body to successfully pass the certification audit. We also managed the Document Control Management System during the development and implementation of the Quality System.

RQMIS Approach:

A Senior Quality Consultant and Technical Writer were assigned to the project. The Sr. Quality Consultant managed the project. Frequent teleconferences were utilized.

Over a period of 2 months, a complete Quality System was designed with the cooperation of the Client. The Quality Manual, SOPs, WIs, and related forms were customized to the actual operations taking place at the EU facility. RQMIS does not take the approach of simply providing “canned” Quality System procedures that so many consulting companies provide. They rarely reflect the true activities that a customer wants to follow. Our approach is to understand how the customer wants the operation to perform.

Since RQMIS consultants have deep operational experience in other medical device companies they are able to provide suggestions on how an operation can be designed more efficiently while still being compliant with the standards/regulations.

Challenges And Issues:

  • Develop a pipeline of OEM-supplied medical devices.
  • Required the establishment of a Quality System that was particularly focused on the management of suppliers.
  • EN/ISO13485 compliant Quality System with a Risk Management process compliant with EN/ISO14971.
  • Establishment of a Technical File for each product family that complemented the OEM design history file.
  • Design and control of own labeling to assure compliance with OEM design file.
  • The customer is located in China, the new company is located in Germany and RQMIS is located in the United States.

Benefits/ Results:

The client now has a fully operational company in the EU, which is EN/ ISO13485 Certified. By utilizing RQMIS minimal internal resources were consumed.

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Contact RQMIS at info@rqmis.com, call us at (978) 358-7307, or just click the Contact button below.


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