Medical devices – Quality management systems requirements

Many companies are in the process of upgrading their management systems to include Aerospace and Medical certifications. Registration to these Standards is the key to diversifying your client base.

Management Solutions Group, Inc. has been in the forefront of this effort to provide our clients with assistance in training and implementation. We hope that the following information will be useful as you explore new opportunities in the medical device industry.

This standard is based on ISO 9001: 2000 as are IATF 16949: 2002 and AS 9100 B. Therefore companies that have a strong ISO 9001 or TS 16949 system will find that they have many of the required processes in place. They will still, however, need to address the requirements specific to the medical device industry as required in ISO 13485. We will highlight some of the additional and specific requirements here.