“These certifications are granted to individuals who have demonstrated a clear understanding of the Medical Device Design Control Process, and posses a clearly written and compliant set of procedures for federal medical device product design quality and regulatory compliance from product concept to transfer to production. The overall results from the training indicate that Voler’s process is a very comprehensive solution for the medical device industry. Certification is recognition of attaining advanced knowledge, quality and skills in the product medical device design control process,” stated Barry Craner, CQA-Biomedical Auditor and ASQ Fellow.
“We’ve designed devices for animal trials and proof of concept evaluation. With this certification we are extending our design practice to include the design of production devices for human use. Some existing customers are interested in this new capability as well as some new prospects that are eager to have us develop the complete product under our Design Control, so they can transfer it directly into production,” said Walt Maclay, president of Voler. “Our company has been at the forefront of design of high quality, yet cost-effective medical device products. The company’s first medical device was designed in 2002.”
The primary objective for the certification was to examine Voler’s ability to meet the strict requirements for federal and European design control quality and safety requirements that include:
- FDA 21CFR 820.30 Quality System Regulation – Design control
- ISO 13485:2003 quality management systems – requirements for regulatory purposes
The certification establishes Voler as one of the industries leading providers of medical devices. Voler has a broad understanding of sensor and measurement electronics and can address them effectively in the integrated design, development and risk assessment of new medical devices. In particular, Voler is familiar with regulatory process and procedures and has the expertise to apply them within the context of a multidisciplinary team.
Voler has demonstrated these capabilities by delivering quality products on time and on budget:
- Catheter to measure the temperature inside the body
- Heart valve tester
- Proof-of-concept device with specialized sensor electronics
- Prototype circuit in a catheter to measure impedance of heart muscle