Rook Quality Systems

Description

• Rook Quality Systems specializes in the creation and implementation of Quality Systems for Startup Medical Device Companies. Implementation of Quality Systems, Consultants work with company to develop sound quality system foundation based on regulatory goals of product. Quality Professionals experienced with small to large medical device companies on creation, installation, and implementation of Quality Management Systems. Consultants work to train employees on the goals and responsibilities within the QMS and continual improvement of product through Quality Metrics. Technical Writing, Rook consultants will work with your Engineers, R&D, and Manufacturing personnel to write all documentation and tailor them to your Quality Management System. Employee training is also available for the implementation of Change Control and continual improvement of the Quality Documents. Rook consultants are proficient in Word, TrackWise, and Excel including all spreadsheet validations. Software and Design Validations may also be completed by Rook consultants for your device. Regulatory Consultation, Rook works to implement systems that are tailored to the product and target correct market and regulatory bodies. Systems for FDA, Health Canada, CE Mark/MDD, and JPL regulated markets as well as smaller regulatory bodies can be created. ISO Counseling, the implementation of ISO 13485 is a practical necessity for all QMS in the current Medical Device environment. Rook has helped install and develop ISO Certified QMS programs for multiple companies. On site counseling and representation may also be provided during the ISO Audits as needed for each company. Internal Audits, Rook consultants can perform internal audits, create an internal audit program for your company and train employees on correct audit procedures and follow up procedures. Rook may also be used to conduct supplier audits upon the clients request.
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  Headquarters: , Atlanta, Georgia, United States

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  Phone Number:

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  Website: https://www.rookqualitysystems.com

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  Employees:11

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  Revenue:$1 - 10M

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  Legal Name:Rook Quality Systems

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• |  NAICS Code: 332994  |

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