Regulatory and Quality Solutions achieves ISO 9001:2008 certification

Regulatory & Quality Solutions LLC

Regulatory and Quality Solutions (RQS) is proud to announce that they have achieved ISO 9001:2008 certification through BSI America. ISO 9001:2008 is based on a number of quality management principles including a strong customer focus, the motivation and commitment of top management, a disciplined process approach to business, and mechanisms for continual improvement. All of which RQS believes are essential to exceeding their client’s expectations.

According to RQS president, Maria Fagan, “We work with many of our clients to help them understand the benefits of having an effective quality management system of their own. It seemed fitting that we achieve certification to ISO 9001:2008 ourselves to complement our business and walk the talk.”

ISO 9001:2008 can be used by any organization, large or small, regardless of the activity at the organization. ISO 9001:2008 has been implemented by over one million companies and organizations in over 170 countries. Using ISO 9001:2008 helps ensure that customers get consistent, quality products and services, which in turn brings many business benefits to the certified organization.

About Regulatory and Quality Solutions LLC

Regulatory and Quality Solutions partners with medical device companies to support the life-cycle of medical devices from conceptual development through post-market surveillance.  The RQS partnership extends to medical device companies’ systems, from the development of a business-balanced QMS to FDA remediation.  The partnership results in accelerating a company’s success in many areas including: navigation of regulatory pathways, investor due-diligence, safety risk management, usability engineering, design verification and validation, clinical evaluations, regulatory submissions, supplier qualification, process validation, auditing, and comprehensive quality system development and support.  To learn more, visit us at www.raqasolutions.com.

Tech 50 preview: Solution Provider of the Year

Don’t miss Tech 50 on November 1.

The Tech 50 Awards gala event is only a few weeks away so be sure to learn a little bit about each finalist beforehand. Below, are brief descriptions of finalists in the Solution Provider of the Year category. More information on each finalist can be found by navigating to each company’s website. Look for a preview of each Tech 50 category on TechBurgher every other business day until the event on November 1.

For more information on the Tech 50 event or to register, contact the PTC Events Team at (412) 918-4229.

AEC Group, Inc.

AEC Group is an end-to-end technology solutions provider that focuses on delivering infrastructure, virtualization and communication solutions to its customers. AEC helps organizations leverage best-of-breed technologies to address business challenges.

Computer Aid, Inc.

CAI/Pittsburgh is an I.T. firm that specializes in software maintenance and support, with performance-based SLAs. From 2006 to 2011, CAI/Pittsburgh quadrupled headcount and more than doubled revenue. This phenomenal growth was enabled by the company’s focus on metrics-based IT support, leveraging the methodology defined by the Software Engineering Institute at Carnegie Mellon University.

Confluence

Confluence provides financial, marketing and regulatory solutions that enable investment management firms to reduce costs and eliminate errors through automation and consolidation of business processes. The software firm is the leading provider of automated data management solutions for the investment industry.

Data Science Automation, Inc.

DSA automates and educates the world’s leading
companies, providing CSIA-certified best practices and LabVIEW-based Adaptive Automation engineering, programming, consulting and training services. In 2011, DSA was awarded a several multi-million dollar contracts to automate hydraulic fracturing controls and data acquisition in the field for natural gas exploration firms working in the Marcellus Shale Play.

Eaton Corporation

Eaton is a global technology leader in diversified power management solutions that enable electric, hydraulic and mechanical power operate more efficiently, effectively, safely and sustainably. Last year, Eaton won a $27 million electrical contract to support design and construction of a third set of locks in the Panama Canal expansion program.

Industrial Testing Laboratory Services, LLC

Industrial Testing Laboratory Services (ITLS) is a multi-faceted materials testing laboratory that supports energy providers including the defense and commercial nuclear industries. This specialty has set ITLS apart in the laboratory testing industry, allowing the firm to branch out into testing in other industries.

 Newton Consulting, LLC

Newton Consulting is a leading provider of information technology, business strategy and human resource management consulting services for growing companies in the Pittsburgh region, across North America and Europe. In 2011, the company successfully launched a wholly-owned subsidiary in London to serve the growing European marketplace.

Regulatory & Quality Solutions, LLC

Regulatory & Quality Solutions provides full-service regulatory affairs and quality assurance expertise to medical device organizations in western Pennsylvania, helping these companies bring new medical devices to market faster.

SDLC Partners

SDLC accelerates execution for its customers focusing on the balance between speed-to-market, cost and quality. SDLC’s capabilities are delivered through three practices areas: business transformation, business intelligence and technology services. SDLC opened its Downtown Solutions Center in September 2011 to create partnering opportunities with clients and to retain top talent in the Pittsburgh market.

Summa Technologies

Summa provides high-impact I.T. consulting services and customized, commercial-grade software development and integration, helping companies evaluate and implement I.T. application modernization strategies to better meet business objectives.

TMG Electronics and Regulatory and Quality Solutions team up for TMG’s ISO 13485 Certification

Regulatory & Quality Solutions is also a Tech 50 finalist.

TMG Electronics has received Certificate of Registration for ISO 13485:2003. Compliance with ISO 13485 demonstrates that TMG has met the requirements for a comprehensive management system, which will enable the successful manufacture of medical devices.  ISO 13485 is widely accepted as the international standard to address medical device regulations worldwide and is a system that is designed to ensure quality manufacturing of medical devices.  This designation recognizes TMG Electronics’ commitment to quality and customer satisfaction.

TMG specializes in custom electronic assembly solutions and currently manufactures medical devices.  TMG is seeking to expand their medical device footprint and obtaining ISO13485 poises TMG for expansion in this regard.  TMG is a customer-driven organization with a commitment to comprehensive customer service and superior quality product. 

TMG collaborated with Regulatory & Quality Solutions LLC to prepare for registration.  RQS provides full-service regulatory and quality assurance expertise to medical device and contract manufacturing organizations.

This Certificate of Registration was granted by BSI Group.  BSI was founded in 1901 as the Engineering Standards Committee, and has grown into a leading global independent business services organization, providing standard-based solutions in more than 140 countries.

To learn more about TMG, please visit www.1tmg.com

To learn more about RQS visit www.raqasolutions.com

Regulatory & Quality Solutions honored as one of Pittsburgh’s fastest growing companies and one of the best places to work

Regulatory & Quality Solutions

Regulatory and Quality Solutions LLC (RQS) is privileged to announce being honored as both one of Pittsburgh Business Times’ 2012 Pittsburgh 100 Fastest Growing Companies and 2012 Best Places to Work.  RQS was also in the top 25 in the 2011 Best Places to Work Award.

The 2012 Pittsburgh 100 is awarded to the fastest-growing, privately owned companies in the Pittsburgh region based on sales growth between 2009 and 2011.  Rankings for this award will be presented on August 23rd at the Duquesne Club.

The Best Places to Work honor is awarded by scores generated from employee participation in a short, confidential survey to assess their workplace.  Rankings for this award will be presented at a luncheon on October 17th at the Duquesne Club.

Maria Fagan, President of RQS believes that winning both awards simultaneously is a testimonial to the great team members that are part of RQS.  It is their team orientation, technical competency, and cohesiveness as a unit that enables them to not only enjoy their work but also be laser-focused on customer success; these two things together have resulted in our fast growth and continued team member satisfaction.    We are honored to have received both awards in the same year and will continue to strive for the same in the future.

About Regulatory and Quality Solutions LLC

Regulatory and Quality Solutions partners with medical device companies to support the life-cycle of medical devices from conceptual development through post-market surveillance.  The RQS partnership extends to medical device companies’ systems, from the development of a business-balanced QMS to FDA remediation.  The partnership results in accelerating a company’s success in many areas including: navigation of regulatory pathways, investor due-diligence, safety risk management, usability engineering, design verification and validation, clinical evaluations, regulatory submissions, supplier qualification, process validation, auditing, and comprehensive quality system development and support.  To learn more, visit us at www.raqasolutions.com.

Regulatory & Quality Solutions announces addition of Judith Hall as Director of Clinical Research

Regulatory and Quality Solutions LLC (R&Q Solutions) is pleased to announce the addition of Judith Hall as Director, Clinical Research.

“Judy’s exceptional leadership in clinical investigations has jumpstarted the launch of R&Q Solutions’ CRO services.  She’s leading clinical studies for our clients in multiple US locations as well as India!” said Lisa Casavant R&Q Solutions Vice President.  Judy has been a Registered Nurse for nearly thirty years and possesses extensive industry and academic research experience.  With strong personnel and project management skills, she is a highly experienced and skilled leader capable of overseeing multiple, complex projects from start to finish.  She has held leadership positions with Stanford University, Natus Medical, Olsten Kimberly Quality Care, Perinatal Advisory Council of Los Angeles Communities, University of Southern California School of Nursing, and many more. Hall holds an English degree from the University of California, Berkeley, and a Nursing degree from the University of Akron.