Shoebar Associates
Medical Devices, 199 Needham Street, Dedham, , 2026, Massachusetts, United States, 1-10 Employees
Phone Number: +15*********
Who is SHOEBAR ASSOCIATES
ShoeBar Associates focuses on services related to software application and development for companies in the FDA-regulated area (medical devices and diagnostics, biotechnology, pharmaceuti...
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Headquarters: 199 Needham Street, Dedham, Massachusetts, 2026, United States
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Date Founded: 2004
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Employees: 1-10
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Revenue: Under $1 Million
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Active Tech Stack: See technologies
Industry: Medical Devices
SIC Code: 3841
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NAICS Code: 541611 |
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Frequently Asked Questions Regarding Shoebar Associates
Answer: Shoebar Associates's headquarters are located at 199 Needham Street, Dedham, , 2026, Massachusetts, United States
Answer: Shoebar Associates's phone number is +15*********
Answer: Shoebar Associates's official website is https://shoebarassoc.com
Answer: Shoebar Associates's revenue is Under $1 Million
Answer: Shoebar Associates's SIC: 3841
Answer: Shoebar Associates's NAICS: 541611
Answer: Shoebar Associates has 1-10 employees
Answer: Shoebar Associates is in Medical Devices
Answer: Shoebar Associates contact info: Phone number: +15********* Website: https://shoebarassoc.com
Answer: ShoeBar Associates focuses on services related to software application and development for companies in the FDA-regulated area (medical devices and diagnostics, biotechnology, pharmaceutical, and vendors to any of these). * Software Validation: Project evaluation, project planning, document preparation, test development and testing, and reporting. * Part 11 Evaluation: Assessment of systems and/or processes, and improvement suggestions, for complying with the Electronic Records and Signatures regulation. *Software Quality Systems: Process evaluation, compliance suggestions, and assistance in developing the needed SOPs. * Agile Transition: Training and assistance with implementing Agile methods for regulated medical software development (through special collaboration with Lean-Agile Partners) * Auditing: Vendor auditing or independent auditing of the client’s software validation or software-related processes. * Training: Targeted, on-site employee training on software validation, electronic records and signatures, and quality processes for software. * Regulatory Consulting: Level of concern evaluation, tracing of development documentation to regulatory guidances and international standards. All services are scaled to the client’s business area, size, and employee background.
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