ShoeBar Associates
Medical Equipment ManufacturingMassachusetts, United States0-1 Employees
ShoeBar Associates is a small firm based in Dedham, Massachusetts, serving the medical equipment manufacturing sector through software-focused services. It concentrates on software application and development work for FDA-regulated industries, including medical devices, diagnostics, biotechnology, and pharmaceuticals, as well as vendors to those sectors. The firm provides support across the life cycle of regulated software, from validation and test development to documentation and reporting. It also offers evaluations for 21 CFR Part 11 compliance, guidance on quality systems, and assistance in creating necessary standard operating procedures. In addition, ShoeBar Associates conducts regulatory consulting, vendor or independent software process audits, targeted on-site training, and Agile transition support in collaboration with Lean-Agile Partners. The company’s services are tailored to the client’s specific business area, size, and employee background.