NEED TO KNOW
Voler Achieves ASQ Certification for Medical Device Design Expansion
A medical device design company that previously provided prototypes, custom test systems, devices for animal trials, and proof-of-concept evaluations is expanding its services to include the design of medical devices for human use. To ensure compliance with government medical device design control regulations as it prepares to upgrade its capabilities and expand its workforce, Voler (Sunnyvale, CA) has sought independent certification and instruction from a Fellow of the American Society for Quality (ASQ).
Certifications are awarded to those that have attained advanced knowledge, quality, and skills in the product medical device design control process. They acknowledge that individuals follow a clearly written set of procedures that comply with federal medical device product design quality and regulatory standards, from product concept to transfer to production. The ASQ certification process indicates that a company's procedures offer a comprehensive means for meeting the needs of the medical device industry.
For Voler, the primary objective of the certification process was to examine its ability to meet the strict requirements of federal and European design control quality and safety requirements, including FDA 21 CFR 820.30 rules for quality system regulation and design control and ISO 13485:2003 requirements for quality management systems.
With expertise in sensor and measurement electronics, Voler claims it is familiar with regulatory processes and procedures and has a multidisciplinary team that can deliver a range of products, including catheters that measure body temperature, heart-valve testers, proof-of-concept devices containing specialized sensor electronics, and prototype circuits for catheters that measure heart-muscle impedance.