Make it happen quickly and efficiently.
Contact RQMIS at info@rqmis.com, call us at (978) 358-7307, or just click the Contact button below.
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.
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.
The client now has a fully operational company in the EU, which is EN/
ISO13485 Certified. By utilizing RQMIS minimal internal resources
were consumed.
Make it happen quickly and efficiently.
Contact RQMIS at info@rqmis.com, call us at (978) 358-7307, or just click the Contact button below.