QA/RA Consulting Group, Inc. Logo - medical devices

QA/RA Consulting Group, Inc.

medical devices
China's Best One-Stop Medical Equipment Provider
About

QA/RA Consulting Group is a privately owned firm located in Pittsburgh with a global presence. We provide domestic and international Quality System Implementation, Supplier Management, Auditing, Regulatory, and New Product Development QE services. With a Net Promoter Score of 100%, our firm strives to provide a deliverable that exceeds our client's goals in terms of cost, quality and outcome. Through diligent cost management and low overhead, we are able to provide the most competitive rates. Our team consists of seasoned quality and regulatory professionals with years of industry experience, who build relationships on trust, integrity and unmatched client focus. www.qaraconsultinggroup.com We Specialize In... • Assisting organizations in the development of effective and efficient regulatory compliant quality systems and processes which ensure the manufacture and delivery of high quality products and services to their customers. • Providing guidance and support to domestic and international companies navigating the regulatory landscape (FDA, CE Mark, ROW) with new product entries into the marketplace. • Providing medical device development teams with Usability and Human Factors Engineering Services to ensure compliance with FDA and MDD requirements. • Supporting organizations by supplementing their own staff to address capacity issues. Mission Statement: QA/RA builds relationships on trust, integrity and unmatched client focus. We will provide the experience and knowledge required to guide your company through the global quality and regulatory requirements that you are facing. Our organization will consistently exceed your expectations through an extraordinary work ethic and by deploying industry best practices.

Technologies
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Keywords
regulatory strategies devices drugs biologics global medical device approval & registration quality system development audit combination products devices usability engineering & human factors quality system auditing qms development design and development device registration and listing sterilization and validation post-market surveillance testing laboratories and services medical device compliance fda warning letter support eu mdr compliance auditing and inspection global regulatory compliance design controls medical devices risk management regulatory affairs ivd regulatory support eu mdr transition support product development combination device regulation b2b data integrity
Company Information
  • Employees 2
  • Founded 2012
Location

3335 Tuscarawas Rd, Beaver, Pennsylvania, United States, 15009

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