QUALITY SYSTEMS

The design and implementation of quality systems and manufacturing/servicing programs saves time and money. Efficiently analyzing and correcting flawed quality systems programs helps reintroduce products or services to the market…and keeps them on the market…

GLOBAL REGULATORY COMPLIANCE FOR MEDICAL DEVICES

KARA & ASSOCIATES can assist with your medical device regulatory needs. We help assure compliance with global regulations including FDA, MDSAP, EU Regulations and ISO requirements…

ON SITE TRAINING

KARA & Associates can help train and support your staff. Well-trained and knowledgeable personnel will create a more seamless blend of your company’s regulatory, marketing, and technical departments. Our customized training solutions deliver fast, effective results…

NEW!

EU Medical Device Regulation (MDR) 2017/745 QMS Auditor Training Course

2-Day Virtual Learning • October 15-16, 2025

Get in-house personalized EU MDR internal auditor training delivered to your team.

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