ERP Software for Medical Device Manufacturers
The FDA is going to audit your ERP. Not literally, but effectively. During a 21 CFR Part 820 inspection, your Device History Records, Design History Files, CAPA records, and lot traceability need to be available and defensible. If your ERP was not built to support that, you are going to be generating those records manually or from spreadsheets, and that is both a compliance risk and a lot of unnecessary work.
What to look for
The compliance architecture needs to be native. That means DHR and DHF management in the system, CAPA workflows with proper audit trails, deviation tracking, and document control that is integrated with production records (not a separate quality system that you hope stays in sync with your ERP). Lot traceability to the component level is the other core requirement. An FDA inspector should be able to start from a finished device and trace back to every raw material lot, every supplier, and every operator involved. If that takes more than a few clicks, the system is not doing its job.
Electronic signatures (21 CFR Part 11) matter if your process requires them. If you are not sure whether Part 11 applies to your operation, that is worth a conversation with your regulatory affairs team before you go live on anything.
42 options, ranked by mfgselect score
Scored across SMB implementability, vertical depth, tech modernity, documentation, user sentiment, and pricing transparency.
Web-native ERP with published pricing, native accounting, and no-code configurability. Remarkably broad vertical coverage out of the box — from electronics and OEM/ETO to job shop, distribution, and process manufacturing. On-premise option available.
Pricing is unusual and transparent — $50/user/month. Vertical breadth — electronics, OEM/ETO, job shop, distribution, even process/chemical — signals genuine architectural flexibility and no-code configurability. Native accounting included. Full ERP out of the box, at a price point that shouldn't be possible.
Published pricing ($50/user/mo), cloud-native since day one, compliance-ready for AS9100/ITAR — the best TCO transparency and SMB accessibility in the contract manufacturing segment.
One of the cleanest options for medical device and regulated manufacturers. Handles 21 CFR Part 11, ISO 13485, QMSR, and FDA Part 820 out of the box. Combines ERP and QMS in one validated platform.
Pre-validated FDA/ISO 13485 platform with fast SMB implementation (3–4 months), IQ/OQ/PQ documentation included — one of the most accessible regulated-manufacturing options available.
Not an ERP — a quality management system for medical device manufacturers. Pre-validated for FDA 21 CFR Part 820, ISO 13485:2016, and EU MDR. Strong in DHF, DMR, CAPA, and complaint management.
This is a QMS, not a full ERP. It excels at what it does — regulatory compliance and quality records for medical device companies — but you'll still need a separate ERP for production and financials.
Best purpose-built medical device QMS for SMB teams — weeks-to-live onboarding, strong DHF/DMR workflows; penalized for significant 2025 price hikes, no public pricing, and multi-year contractual lock-in.
Consumption-based pricing (not per-seat) is a real differentiator at the mid-market level. Best modern option for distribution-heavy operations. Strong field service and retail modules.
Strong mid-market ERP with genuine cloud-native credentials and consumption-based pricing — well suited to growing distributors and mixed-mode manufacturers, but a horizontal platform that requires configuration to reach vertical depth, and implementation complexity means it performs best for companies with dedicated ops resources rather than first-time ERP buyers.
Cloud-native PLM with strong quality management. Trusted by 1,500+ companies for BOMs, engineering changes, supplier collaboration, and compliance documentation. Best at the intersection of electronics and medical.
This is an engineering/PLM system, not a manufacturing ERP system.
Strong cloud PLM+QMS for medical and electronics, 1,450+ deployed companies, QuickStart fixed-fee implementation — TCO opacity and no published list pricing are the main friction points.
Cloud-native, built by machinists for machinists. Exceptional quality and compliance tooling — AS9100, ITAR, NADCAP built in, not bolted on. Widely used in aerospace supply chain.
One of the most honest job shop ERPs on the market — built to run the founders' own machine shop before it became a product. Compliance tooling is best-in-class for AS9100 and ITAR environments. Note: likely built on Microsoft / .NET tech stack made popular in 1990s and 2000s.
Excellent aerospace job shop fit with AS9100/ITAR built in, strong SMB reviews from the machining community — penalized for underlying .NET stack and no publicly listed pricing.
Cloud QMS built for early-to-mid stage medical device, pharma, and biotech companies. Covers document control, design controls, CAPA, risk management, and audit management. Easier to implement than MasterControl and better calibrated to companies under 500 people.
If Greenlight Guru is too device-centric and you’re in pharma, biotech, or software as a medical device (SaMD), Qualio is the stronger fit. For pure physical device DHF/DMR workflows, Greenlight Guru still has the edge.
Solid SMB medical QMS with 4.4/5 G2 across 719 reviews — penalized for recent price increases, no public pricing, and multi-year commitment patterns emerging in 2025.
Purpose-built QMS for medical device and pharmaceutical manufacturers. Covers document control, training management, CAPA, complaints, audits, and supplier quality. Designed to be accessible for 10–200 person medical device companies without a dedicated IT team.
Strong SMB-accessible QMS for medical device — published pricing, self-guided implementation, and compliance depth (ISO 13485, FDA 21 CFR) are genuine differentiators for smaller medical device manufacturers.
Cloud quality management and application lifecycle management for medical device and regulated manufacturers. Covers design controls, risk management, CAPA, document control, and FDA 21 CFR Part 11. More accessible than MasterControl for smaller medical device companies.
SMB-accessible cloud QMS for medical device — FDA 21 CFR Part 11 compliance, design controls, and risk management without enterprise complexity; published pricing and accessible onboarding are key advantages.
Built 100% on the Salesforce platform — if your team lives in Salesforce CRM, this is the most natural ERP extension. Genuinely strong in ETO, project-based, and configure-to-order environments.
Rootstock requires buying in whole-sale into the Salesforce ecosystem.
Salesforce-native and recognized SMB ERP leader — strong for ETO and project-based mfg, but dual Salesforce+Rootstock licensing cost and no public pricing add real friction for buyers.
Quality management system built 100% on the Salesforce platform — for medical device, biotech, and pharmaceutical companies. Covers document control, training, CAPA, complaints, and audit management. Best fit for companies already on Salesforce CRM.
Solid Salesforce-native QMS for life sciences — excellent fit if already on Salesforce; FDA and ISO compliance depth is real; Salesforce dependency adds licensing cost for companies not already on the platform.
Precision traceability platform for EMS and high-reliability PCBA manufacturers. Records component-level data for every board — materials, process settings, measurements — with full forward and backward trace. Open architecture integrates with MES and ERP systems.
Narrower scope than Aegis FactoryLogix — Cogiscan is a precision traceability instrument rather than a full MES. Best fit for shops with strict IPC-1752, AS9102, or FDA traceability requirements.
Best-in-class component-level traceability plugin for IPC-1752, AS9102, and FDA-regulated PCBA — purpose-fit score is high within its niche; no public pricing is the main friction.
Cloud PLM built on Salesforce — connects product development to quality and commercial operations in one platform. Growing adoption in medical devices and electronics. If your team already lives in Salesforce, this is a natural extension.
Modern Salesforce-native PLM with growing medtech adoption — dual Salesforce+Propel licensing cost and no public pricing add meaningful friction; strong if you're already in the Salesforce ecosystem.
Modular architecture means you only pay for what you use. Massive global community and partner network. Implementation quality varies wildly by partner. Best for companies with in-house technical resources.
Open/custom platform — modular open-source core with a large global partner ecosystem. Outcomes vary widely by partner quality; heavy customization can complicate future version upgrades. Best for companies with in-house technical resources or a strong implementation partner.
Excellent transparency (published pricing), modern tech, and great docs — but low manufacturing vertical depth and highly variable partner quality mean outcomes range from excellent to disastrous.
Purpose-designed for startup-to-mid-size manufacturers building complex products from BOMs: electronics, medical technology, instruments, and industrial equipment. Published pricing, self-guided implementation, and 95% user satisfaction. Lacks CRM and multi-currency — right-sized for focused US manufacturers under 150 employees.
Does not include native CRM or multi-currency. Best for US-based sub-150-employee manufacturers building complex products from BOMs. Not suited for international operations, process manufacturing, or companies needing integrated sales pipeline management.
Best-fit ERP for fast-growing electronics and med-tech manufacturers — published pricing, high satisfaction scores, and purpose-fit for complex BOM environments; the scope is intentionally narrow (no CRM, no multi-currency) which is a feature for its target buyer, not a bug.
Salesforce-native enterprise quality management suite. Covers document control, CAPA, audits, complaints, training, and supplier quality on a single platform.
One of the few QMS platforms built natively on Salesforce, giving it built-in CRM integration, security model, and workflow engine. Strong for companies already on Salesforce. Broader compliance suite than typical QMS — covers EHS alongside quality. Particularly valued in medical device, life sciences, and aerospace where supplier quality management is critical.
ZenQMS is a cloud-based quality management system for life sciences companies — pharma, biotech, and medical device manufacturers. Covers document control, training management, CAPA, deviations, audits, and change control with full 21 CFR Part 11 compliance. Simple enough for small companies, scalable for mid-size.
Strong cloud QMS for life sciences with genuine regulatory compliance depth and transparent pricing — ZenQMS hits the right balance between affordability and compliance rigor for SMB pharma and medical device manufacturers that can't justify enterprise QMS costs.
Family-owned and US-based. Extremely loyal customer base in small and mid-size job shops. Proven on-prem product with a cloud option. One of the few vendors focused exclusively on this segment.
Extremely loyal SMB job shop base and a proven product — held back by $75–200K first-year implementation cost, legacy tech architecture, and no published pricing.
Unifize is a cloud platform for manufacturing quality and process management built around real-time collaboration. Covers CAPA, non-conformances, engineering change orders, complaints, and supplier quality — with a conversational interface that embeds quality workflows into day-to-day team communication.
Differentiated by its conversational, collaboration-first quality workflow design — Unifize makes quality workflows feel like Slack rather than traditional QMS software, which significantly improves frontline adoption in manufacturing environments.
Hexagon's enterprise quality management platform — used by medical device, pharma, aerospace, and food manufacturers for FDA compliance, ISO management, CAPA, and audit management. Enterprise scale, deep configurability, broad regulated industry coverage.
Enterprise QMS with broad regulated industry coverage — deep compliance capability but enterprise pricing, SI (systems integrator)-required implementation, and no self-serve access limit SMB suitability.
48 more options available in the interactive directory, where you can filter by budget, tech type, and company size.
General fit — not purpose-built
These systems can work for this vertical but were not designed specifically for it.
No-code manufacturing app platform — lets operators and engineers build shop floor apps without coding. Work instructions, quality checks, machine monitoring, and traceability built visually. Used by manufacturers replacing paper and clipboards on the production floor. Works alongside existing ERP.
Best-in-class no-code shop floor platform — genuinely accessible for manufacturers without software engineers; works alongside existing ERP rather than replacing it; strong IoT connectivity and growing ecosystem.
Deep job shop DNA going back decades. Quote-to-cash workflow covering estimating, scheduling, shop floor control, and quality. Strong in small-to-mid machining and fabrication shops.
Deep job shop DNA going back decades — dominant name in machining ERP, but legacy-hybrid architecture, SI (systems integrator)-dependent implementations, and opaque pricing pull it below modern alternatives like Cetec or ProShop.
Cloud PLM purpose-built for hardware product companies — BOM management, engineering change orders, document control, and quality workflows in one accessible platform. Strong for medical device and instruments companies that need FDA 21 CFR Part 11 compliance without enterprise complexity.
Accessible cloud PLM for hardware startups and smaller medical/instruments companies — compliance-ready without enterprise complexity; published pricing and self-serve onboarding are genuine SMB advantages.
Net-Inspect is a web-based quality management system purpose-built for aerospace manufacturing — first article inspection (FAI), source inspection, supplier quality, and FAIR/AS9102 compliance reporting. Used by aerospace primes, Tier 1 and Tier 2 suppliers, and MRO operations across the aerospace supply chain.
Best-in-class for aerospace first article inspection and supplier quality — Net-Inspect is the de facto FAI tool in the North American aerospace supply chain, with strong adoption across Tier 1 and Tier 2 suppliers; scope is narrowly focused on aerospace quality rather than full QMS.
Israeli-origin ERP with a strong track record for mid-market manufacturing and distribution globally. True cloud, HTML5 UI, mobile-first architecture. MRP, BOM, shop floor, quality, and native financials in one system. Rare in this tier: published pricing. Stronger EMEA presence than US, but growing internationally.
Stronger presence in Israel, Europe, and Latin America than in North America. US implementations typically require a local partner. Published pricing available at priority-software.com — worth requesting before comparing to opaque alternatives.
Genuinely modern mid-market ERP with published pricing — a rare combination at this tier; solid manufacturing coverage and a proven EMEA track record, though US market presence and English-language partner density are lighter than US-native alternatives.
Advanced planning and scheduling platform for mid-market manufacturers. Integrates with SAP, Oracle, Microsoft, and Infor ERPs to add constraint-based finite scheduling.
Leading mid-market APS system that bolts onto existing ERPs to deliver finite capacity scheduling, what-if scenario planning, and visual drag-and-drop boards. Well-suited for manufacturers who have outgrown their ERP's scheduling module but do not want to replace the whole system. Requires ERP as the system of record.
Purpose-built for custom, ETO, and high-mix manufacturers. Strong CAD-to-BOM integration, job costing, and project tracking. Good fit for shops that take complex one-off or short-run contracts.
Good ETO and custom manufacturing focus for SMBs with genuine CAD-to-BOM strength — no public pricing and limited documentation depth keep it in the viable-with-tradeoffs tier.
WinMan is a UK-founded web-based ERP for small and mid-size discrete manufacturers. Covers the full ERP suite including accounting, BOM, production scheduling, and MRP. Strong presence in UK/Ireland; growing North American footprint via US office.
Genuinely web-native architecture with strong discrete manufacturing depth and published pricing transparency — underrated in North America due to UK origin, but a solid contender for SMB discrete mfg buyers willing to evaluate beyond the obvious names.
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