Business Management Services
ISO 13485 Medical Devices – Quality Management System Consulting
Business Management Services, led by industry veteran Joel Pecoraro, has been helping medical device manufacturers across central Indiana and beyond achieve ISO compliance since 1995. As President of Business Management Services, Joel brings decades of hands-on experience simplifying complex quality system requirements for real-world success.
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Why Choose Business Management Services?
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At Business Management Services, we partner with medical device companies to make ISO 13485 compliance clear, manageable, and achievable. Whether you’re building a new quality management system (QMS) or optimizing an existing one, we bring practical expertise and proven strategies tailored to your business.
Our Mission: Compliance Made Simple
ISO 13485 is the international standard for quality management systems in the medical device industry. Compliance isn’t just about passing audits—it’s about ensuring the safety, consistency, and regulatory readiness of your products. Whether you're manufacturing finished devices or components, we’re here to guide you every step of the way.
Our Core Services
✅ Implementation Consulting
We lead full ISO 13485 implementations—from planning and documentation to deployment and internal readiness. Every system is tailored to your size, product line, and market, ensuring compliance without unnecessary complexity.
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✅ Internal Audits
Our experienced third party auditors conduct comprehensive internal audits to ensure your QMS aligns with ISO 13485 standards. We identify gaps, recommend corrective actions, and prepare your team for certification success.
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✅ Gap Analysis
Already have a QMS in place? We’ll assess your system against ISO 13485 and deliver a detailed roadmap to close any compliance gaps—perfect for upgrades from ISO 9001 or fresh implementations.
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✅ Supplier Evaluation
Your product is only as strong as your supply chain. We assess your key suppliers against ISO 13485 requirements to ensure quality, reduce risk, and maintain compliance across your operations.
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✅ Procedure Development
We help establish your QMS procedures to meet both the standards and your internal needs for efficiency and product safety. Typically covering 10 to 20 core processes, we leverage your existing documentation wherever possible to save time and cost.