Sara Adams

Sara Adams is a medical device guru at Greenlight Guru and a biomedical engineer who began her career in the medical device industry in the post-manufacturing world. As an experienced quality engineer, she has been responsible for leading corrective and preventive action (CAPA) investigations and implementations, process improvements, and supplier and regulatory audits.

Wed, 09/08/2021 - 12:02
What Should Really Trigger a CAPA?CAPA-worthy or CAPA-happy?
Tue, 02/22/2022 - 12:03
Corrective and preventive action (CAPA) is often a thorn in the side of medical device manufacturers. Problems with CAPA top the list of reasons for 483s and warning letters from the FDA year after year, and many companies struggle to identify when…
Five Biggest Quality Management Mistakes in the Medical Device IndustryHere’s how you can avoid making them
Thu, 09/23/2021 - 12:03
At Greenlight Guru, we collectively have hundreds of years of experience in medical device quality management. We’ve all seen some great successes during our time in the industry—high-quality medical devices that improved the quality of life for…
Five Postmarket Surveillance-System Musts for EU Medical-Device ManufacturersEnsuring the safety and efficacy of your medical device
Wed, 09/08/2021 - 12:02
Designing, developing, and getting your medical device approved and onto the market is a huge accomplishment—but it isn’t the end of your responsibilities. For the European Union (EU) market, the European Commission (EC) requires manufacturers to…