IT Consulting for Medical Device Companies
Why Medical Devices?
Medical device companies operate at the intersection of life-critical technology and one of the most demanding regulatory environments in any industry. For IT, operations, and quality leaders at MedTech organizations, the technology decisions that shape your infrastructure, your quality management systems, and your cybersecurity posture are not just operational — they directly affect your ability to bring products to market, maintain FDA clearance, and protect patients.
Turning Point Advisory provides IT consulting for medical device companies with a focus on the specific regulatory, operational, and security challenges facing MedTech organizations. We understand the FDA's Quality Management System Regulation, ISO 13485 certification requirements, the cybersecurity demands of OT/IT environments, and the enterprise technology needs of manufacturers navigating rapid growth or transformation.
We serve CIOs, IT Directors, VP Operations, Quality Directors, and CFOs at medical device manufacturers, contract manufacturers, MedTech startups, and Software as a Medical Device (SaMD) organizations — bringing senior-level IT leadership to the table without the overhead of a full-time executive hire.
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Fractional CIO
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Compliance Technology
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Cybersecurity
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ERP
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Operations Technology
* Fractional CIO * Compliance Technology * Cybersecurity * ERP * Operations Technology
Fractional CIO
The technology decisions facing medical device companies today are more complex than ever — from navigating the FDA's updated Quality Management System Regulation to managing cybersecurity risk in manufacturing environments, selecting and implementing ERP systems that meet validation requirements, and building the IT infrastructure needed to support rapid commercial growth.
Our Fractional CIO service for medical device companies provides executive-level IT leadership on a flexible, part-time basis — giving MedTech organizations the strategic guidance they need at a cost appropriate to their stage and scale.
We bring senior IT leadership to support:
IT strategy and multi-year technology roadmap development aligned with product development, regulatory, and commercial timelines
Evaluation and selection of ERP systems for medical device manufacturers, including systems with built-in validation frameworks for 21 CFR Part 11 compliance
Infrastructure modernization and cloud migration for manufacturing and quality environments
IT team leadership and organizational development for growing MedTech companies
Representation of technology strategy in board conversations, investor due diligence, and M&A processes
Vendor management, contract negotiation, and technology partner accountability
For MedTech startups preparing for first FDA clearance, growth-stage companies scaling operations, and established manufacturers modernizing legacy systems, we provide the experienced leadership that turns complex technology challenges into competitive advantage.
FDA & QMS Compliance Technology
The FDA's finalization of the Quality Management System Regulation (QMSR), effective February 2026, represents the most significant update to US medical device quality system regulations since 1997. By harmonizing 21 CFR Part 820 with ISO 13485, the QMSR creates new demands on the technology infrastructure underpinning your quality management systems — and on the IT leadership responsible for ensuring those systems are validated, auditable, and compliant.
Turning Point Advisory helps medical device IT, quality, and operations leaders navigate the technology implications of FDA and international compliance requirements, including:
FDA QMSR & 21 CFR Part 11
Assessing your current IT infrastructure and eQMS systems against QMSR requirements
21 CFR Part 11 compliance for electronic records and electronic signatures — validation, audit trails, access controls, and system documentation
Preparing IT systems and documentation for FDA inspections and notified body audits
Evaluating and selecting validated eQMS platforms aligned with QMSR and ISO 13485 requirements
ISO 13485 & Global QMS
Technology gap assessments against ISO 13485 QMS requirements — identifying where your current systems fall short and building a remediation roadmap
Implementation oversight for eQMS platforms across document control, CAPA, supplier quality, complaints, training, and risk management
Support for multi-site QMS harmonization across manufacturing, distribution, and service organizations
EU MDR and MDSAP technology compliance support for organizations selling into global markets
Design Controls & DHF/DMR/DHR
IT infrastructure for Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR)
PLM system evaluation and implementation for design control and change management
Data integrity frameworks ensuring traceability across the product development lifecycle
Our approach to compliance technology is practical: we help you build systems that satisfy regulators, support operational efficiency, and create the audit-ready documentation culture that protects the business long-term.
Cybersecurity
Medical device companies face a cybersecurity landscape that is growing in complexity and consequence. Ransomware attacks targeting manufacturing operations, vulnerabilities in legacy OT systems connected to corporate networks, and increasingly stringent FDA cybersecurity guidance for Software as a Medical Device (SaMD) all demand a more sophisticated, proactive security posture than most MedTech organizations currently have in place.
We provide cybersecurity consulting for medical device companies grounded in the operational realities of manufacturing and regulated product development — not adapted from generic enterprise security frameworks.
Manufacturing & OT/IT Security
OT/IT convergence security assessment — identifying vulnerabilities at the intersection of production systems and corporate networks
Network segmentation strategy for manufacturing environments
Incident response planning built around production continuity requirements
Vulnerability management across legacy manufacturing systems that cannot easily be patched or replaced
FDA Cybersecurity Guidance & SaMD
IT compliance with FDA cybersecurity guidance for Software as a Medical Device (SaMD), including Section 524B of the FD&C Act
Cybersecurity documentation for 510(k) and PMA submissions — threat modeling, SBOM (Software Bill of Materials), and vulnerability management plans
Post-market cybersecurity surveillance program design
Enterprise Security
Security roadmap development aligned with company growth, regulatory requirements, and risk tolerance
ISO 27001 and NIST framework implementation for medical device corporate environments
Third-party and supplier cybersecurity risk management
Security program development for MedTech startups building their first security posture ahead of FDA clearance or Series B fundraising
ERP & Operations Technology
Selecting and implementing an ERP system for a medical device company is fundamentally different from doing so in other industries. The system must support validated processes, electronic records compliant with 21 CFR Part 11, design control workflows, serialization and UDI requirements, and the traceability demands of manufacturing regulated devices. Choosing the wrong system — or implementing the right system poorly — can create compliance risk that far outweighs the operational benefits.
We provide ERP consulting for medical device manufacturers at every stage — from requirements definition and vendor selection through implementation oversight and validation support.
ERP evaluation and selection — vendor-agnostic assessment across platforms commonly used in medical device manufacturing, including SAP, Oracle, Microsoft Dynamics 365, NetSuite, Infor, Syspro, and MedTech-specific systems
Implementation project management — senior oversight of ERP rollouts in validated manufacturing environments, where scope management and change control are critical
Computer System Validation (CSV) — IT leadership support for validation activities including IQ/OQ/PQ protocols, risk assessments, and validation documentation
UDI and serialization compliance — technology infrastructure for Unique Device Identifier compliance and traceability across the manufacturing and distribution chain
Legacy system modernization — migration from aging on-premise systems to modern platforms, with full consideration of validation state and compliance continuity
Technology Platform Services
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Layered security controls to prevent attacks, detect threats, and respond quickly when issues arise.
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Conditional access and MFA that protect systems and data without slowing your team down.
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Centralized management, support, warehousing, and shipping for all endpoints, including Mac, Windows, iOS, iPadOS, and Android.
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Reliable backup and recovery across cloud services, servers, devices, and critical infrastructure.
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Proactive management of servers and networks to maximize uptime and protect mission-critical systems.
Who We Work With in Medical Devices
Our MedTech clients range from pre-revenue startups building their first FDA-compliant quality system to established manufacturers managing complex multi-site operations. Common situations that bring leaders to us include:
Preparing for first FDA 510(k) clearance or PMA submission and needing to demonstrate compliant IT systems
Navigating the FDA QMSR transition (effective February 2026) and assessing technology gaps
Evaluating or implementing a new ERP or eQMS system in a validated manufacturing environment
Managing a cybersecurity incident, a failed FDA inspection, or a warning letter with IT system implications
Growing rapidly and needing senior IT leadership without the cost of a full-time CIO
Preparing for acquisition, Series B/C fundraising, or a strategic partnership that requires technology due diligence
If any of that resonates, we would welcome a direct conversation. We are based in Melrose, Massachusetts, and serve medical device companies across New England and nationally.
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Thank you for your interest in Turning Point Advisory
We're thrilled about the opportunity to collaborate with you and your team, and we look forward to connecting with you soon.