At HaA Product Development, we specialize in guiding your innovative medical devices from concept to commercialization in the fast-paced, FDA-regulated market. With over 30 years of experience, we partner with clients of all sizes to bring their visions to life, ensuring that each product not... Read More
MDI Consultants, with over 45 years of expertise, is a premier provider of FDA regulatory compliance consulting, specializing in medical device, pharmaceutical, and food industry sectors. Our comprehensive services support global companies in achieving and maintaining FDA, EU, and Health Canada... Read More
CriTech Research, Inc. specializes in medical device software development, testing, and remediation. CriTech is ISO 13485 certified and provides software engineering services exclusively to the medical device industry. We provide tailored services to include software verification and... Read More
By ETQ
ETQ Reliance 2019 is the most powerful, flexible and easy to use QMS solution available on the market. For customers in industries such as medical devices, life sciences, heavy industrials, food and beverage, electronics, chemicals, aerospace and defense, automotive and commercial aviation-life... Read more »
By ETQ
ETQ Reliance 2019 is a SaaS Quality Management System that provides industry-leading ease of use and powerful flexibility, while delivering best practices from the strongest, most quality-centric companies in the world. ETQ SaaS offers customers a fully managed quality software solution that... Read more »
By ETQ
The FDA has announced plans to transition to standard ISO 13485:2016 for medical devices in April 2019. In addition, the Medical Device Single Audit Program, MDSAP, has gained traction with full implementation set for 2019.
Download this paper to learn more about these two changes from the...
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