Medical device manufacturers are mandated to have and use Quality Systems. These cover everything from product development to manufacturing to distribution. Many company's Quality Systems are off-the-shelf products. We'll bet that your business isn't a cookie cutter of some generic company. Neither should your Quality System. We can help you to have a system that works for your company.

Key Benefits

• Customized systems are easier to use - leading to improved compliance.
• Your quality system will be "right sized" to fit your company, from small startup or virtual company, and grow as your needs increase.
• A good quality system helps to avoid errors and helps to improve your products and services.
• Integrating business systems into your Quality System makes for improved efficiency.

Capabilities

In addition to creating or fixing  your Quality System we can provide experienced personnel to augment (or run) your internal audit program. Many consultants used to be inspectors. They may fully understand the "letter of the law" with regards the regulations, but typically haven't worked themselves under a Quality System.  We have, and can tell you that there is a lot of opportunity for creation of systems that can be effective, compliant, and still capable of being lived within.

FDA and international regulatory agencies require medical device manufacturers to have trained and competent employees.  We can develop and conduct training in all aspects of Quality Systems, particularly design controls and software validation.

Typical First Step - Measure

Gap Audit - typically done when we are first introduced in order to assess your Quality System and how you are working within it.

Improve

Based upon what we find in the audit we decide with you on whether to make evolutionary or revolutionary changes to your system. We can help train your people in their new system too.

Maintain

Once you are working within your improved Quality System we can help with periodic audits, continuous improvement activities, training, support of regulatory inspections, etc.

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Copyright © 2007 NJK & Associates, Inc.
Last modified: 03/19/07