Navigation Links
Voler Expands Medical Device Design Capabilities
Date:11/13/2008

SUNNYVALE, Calif., Nov. 13 /PRNewswire/ -- Voler (http://www.volersystems.com) announced today that it is expanding current medical device design capabilities beyond prototypes and custom test systems to include the design of production medical devices for human use. "Voler continues to invest in upgrades to our medical device design capabilities and to add to our multidisciplinary team," stated Walt Maclay, president of Voler. "In the face of increasing customer demand we sought independent verification and instruction by a Fellow of the American Society for Quality (ASQ), a leader in quality initiatives and quality-assurance methodologies, to ensure compliance with government Medical Device Design Control regulations."

"These certifications are granted to individuals who have demonstrated a clear understanding of the Medical Device Design Control Process, and possess 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 industry's 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

About Voler (http://www.volersystems.com)

Strawberry Tree Inc. and its Voler division have a long history of innovation and outstanding engineering that spans three decades. Since 1979 Strawberry Tree has designed sophisticated and reliable products. We continue to focus on what we have always been best at: high-quality innovative engineering that saves our clients time and money. We offer expert engineering services for new product design and system integration, medical device design, instrumentation design, and data acquisition systems.

Media Contact:

Theresa Shafer

tshafer@skmurphy.com

408-252-9676

This release was issued through eReleases(TM). For more information, visit http://www.ereleases.com.


'/>"/>
SOURCE Voler
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. deCODE Study Expands Clinical Utility of deCODE AF(TM) for Improving the Diagnosis of Atrial Fibrillation and Preventing Stroke
2. Avid Bioservices Expands Capabilities With Installation of Innovative Thermo Scientific HyClone Single-Use Bioreactor Systems
3. DuPont Expands Seed Production Capacity to Meet Growing Demand for Seed, Grain
4. AMDL, Inc. Promotes CFO Akio Ariura to Chief Operating Officer and Expands Management Team
5. PAREXEL Expands Pioneering Asian Ethnobridging Expertise
6. ALine, Inc. Expands Management, Adding Roger Anderson, Ph.D., as VP of Operations
7. Healthcare Scoop Expands Consumer Conversation to Dialogue with Premier Healthcare Organizations
8. NeoStem Secures $250,000 in an Above Market Financing and Expands Its Relationship With New England Cryogenic Center, Inc.
9. Sustainable Oils Names Scott Johnson as General Manager, Expands Management Team for Camelina Research and Production
10. Genstruct Expands Team with New VP of Engineering
11. Ventria Expands Lactoferrin Production
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/12/2017)... ... January 12, 2017 , ... ... of performing routine electrochemical biosensing has increased dramatically. Primarily driven by the ... and quantification of various analytes in complex samples. , Screen-printed ...
(Date:1/12/2017)... Oregon and Pune, India , January 12, 2017 /PRNewswire/ ... vitro Toxicity Testing Market by Type and End Users - Global Opportunity Analysis and ... $7,813 million by 2022 from $2,921 million in 2015, growing at a CAGR of ... ... Allied Market Research Logo ...
(Date:1/11/2017)... Mass. (PRWEB) , ... January 11, 2017 , ... ... in rural and urban clinics in Peru studying the pathogens that cause malaria ... her on a career path of discovery. , Now, as an assistant professor ...
(Date:1/11/2017)... ... January 11, 2017 , ... Microbial genomics leader uBiome, is ... most recent microbiome impact grant award has been made to Dr. Eon Rios ... use of oral antibiotics, prescribed for skin conditions, on the gut microbiome. ...
Breaking Biology Technology:
(Date:12/15/2016)... ... announced the addition of the "Global Military Biometrics Market 2016-2020" ... military biometrics market to grow at a CAGR of 7.5% during the ... an in-depth market analysis with inputs from industry experts. The report covers ... report also includes a discussion of the key vendors operating in this ...
(Date:12/12/2016)... 12, 2016  Researchers at Trinity College, Dublin, ... by combining the material with Silly Putty. The mixture ... detector able to sense pulse, blood pressure, respiration, ... The research team,s findings were ... here:  http://science.sciencemag.org/content/354/6317/1257 ...
(Date:12/7/2016)... , December 7, 2016 BioCatch , ... expansion of its patent portfolio, which grew to over 40 granted and ... , , ... recently filed patent entitled " System, Device, and Method Estimating ... that enables device makers to forego costly hardware components needed to estimate ...
Breaking Biology News(10 mins):