Quality Management

A good, simple quality system should provide a clear path through the medical device development process.  If properly developed and implemented, it may be the most important investment for your company.

Medical Device manufacturers who want to sell their products in the USA are required to comply with FDAs Quality Systems Regulations.  Companies that sell their devices in Europe and many other countries need to comply with ISO 13485.  There are many similarities between both systems. Both systems require a Quality Manual, quality procedures, work instructions, control of documents, quality plans and records related to manufacturing procedures. 

The Quality Systems Regulations have additional requirements for Design Control Documentation, if applicable to the device, and differences in several other areas.

MDAI can provide and implement a Quality Manual and Procedures that will allow your company to be compliant with both FDAs Quality System Regulations as well as ISO 13485.  The system can be implemented either electronically, in paper form or in a hybrid manner that allows a mixture of both mediums.

Work instructions, quality plans, and many manufacturing related records are unique to a company.  MDAI will work with you to develop the necessary documentation to ensure your processes are compliant.

Developing and implementing a Quality System that complies with both QSR and ISO 13485 can be time consuming and very challenging.  Small, start-up companies may not have the funds to hire a full time regulatory / quality person.  In that case, MDAI can act as a “out-sourced” Regulatory/Quality Management department to get your company off to the right start until it is the right time to bring these services in house.

To discuss how Medical Device Approvals can help you achieve your regulatory objectives, please contact us at kathleen@mdapprovals.com