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Press Releases
For Immediate Release
For More Information, Contact:
Bob Yeoman, Managing Director, (610) 868-7183 or bob.yeoman@brcompliance.com
B&R Compliance Associates Introduces a new FDA Compliance and Training program covering Hospital System Installation and Maintenance for Medical Gases
Integrated program ensures customer's operations comply with all new NFPA, CGA, and FDA requirements.
Lehigh Valley, PA - B&R Compliance Associates LLC is pleased to announce the introduction of a new Medical Gas Compliance program created for firms that install and maintain medical gas systems at hospitals and other health care facilities.
This program was created in response to the growing number of firms installing and maintaining hospital systems and their need to stay abreast of new FDA, Industry, and NFPA requirements with the tools and training they need to maintain and grow their business. Its goal is to provide proven procedures and comprehensive training that ensure conformance with the latest requirements to eliminate the risks associated with non-compliance.
The program consists of four components integrated into a system to support medical gas firms operational and compliance needs. These elements are:
- Standard Operating Procedures: A comprehensive set of procedures, forms, and technical information covering system sizing, component and vendor qualification, system installation, system testing and commissioning, documentation requirements, and maintenance activities.
- Training & Certification: A comprehensive training program for technicians, installers, and system designers covering the latest CGA and FDA guidelines, and featuring hands on training with a working system. Brazing Certification is also available.
- Technical & Regulatory Support: Full access to technical, engineering, and regulatory support from some of the leading experts in the medical gas industry.
- Automatic Updates: As regulatory requirements evolve, industry practices change, or new technology is introduced automatic updates to all materials are provided.
This compliance program delivers to medical gas firms a total solution for hospital system compliance, with proven procedures and techniques combined with training and certification that ensures compliance with constantly evolving regulations and requirements, supported by experts with over 50 years combined industry and compliance experience.
B&R Compliance Associates LLC has joined forces with Acme Cryogenics, Inc. to offer a total systems solution. Their joint solution includes both training and compliance services, plus complete fully compliant and validated medical gas supply systems. These complete packages are engineered using Acme's standard operating procedures (SOPs), developed and supported through B&R in conformance to all FDA cGMPs, CGA, and NFPA system requirements. They feature complete bulk supply (i.e. tanks, manifolds, vaporizers, piping, and etc.) and delivery (i.e. manifolds, alarms, etc.) systems custom designed and manufactured to meet hospital customers' unique and demanding requirements. These systems are all pre-qualified for medical service in accordance with the latest FDA requirements. Design and installation, as well as annual certified maintenance inspections are also available.
This innovative combination of equipment and services will allow medical gas firms to retain and grow their business without the uncertainty and expense non-compliance can bring. The total solution approach provides customers with a central resource, eliminating the hassle and cost of qualifying and auditing multiple suppliers. Because Acme and B&R offer continued service options, users will have the peace of mind knowing their compliance program and their hospital systems will remain compliant in the future.
The associates at B&R Compliance Associates LLC have lifetimes of experience in the medical gas business spanning from the production floor to executive management. They specialize in delivering cost effective regulatory solutions, custom fit to customers' business and compliance needs. For more information contact B&R Compliance Associates at (610) 868-7183 or online at www.brcompliance.com.
Acme Cryogenics has been a leading worldwide manufacturer of gas and liquid handling solutions for over thirty-four years. Acme, along with group members, Quality Cryogenics and Acme Specialty Gas Equipment, operates four east coast manufacturing facilities and has multiple sales offices nationwide. For more information on Acme medical gas system package options please contact Acme at (800) 422-2790 or online at www.acmecryo.com.
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